Systems and methods for locating and defining a target location within a human body

ABSTRACT

Systems and methods for locating and defining a target location within a human body. The system can include at least one marker, a probe, and a detector for use in locating the markers by providing information to a surgeon that is representative of changes in proximity between the probe and the marker. The marker can have various detection characteristics, e.g., gamma radiation, that are detectable by an associated probe and detector. The tissue volume is removed by manipulating a cutting tool based on the proximity information provided by the detector, which can be used by the surgeon to define the boundary of the tissue volume. The systems and methods of the invention are particularly useful in locating and then removing a tissue volume or other target location from amorphous, pliable tissue (e.g., breast tissue) or other body parts.

TECHNICAL FIELD

[0001] Several aspects of the present invention relate to systems andmethods for locating a target tissue within a human body with wirelessmarkers. Other aspects of the invention relate to wireless markers,instruments, user interfaces, and methods for using such systems intreating or monitoring a target location.

BACKGROUND

[0002] Many medical procedures require monitoring or treating aninternal tissue mass or other body part within a human body. In suchapplications, medical procedures must accurately locate a small targetlocation within a soft tissue region, an organ, a bone structure, oranother body part (e.g., colon, vascular system, etc.). The small targetlocation can be a lesion, polyp, tumor, or another area of interest formonitoring or treating a patient. One particular application involvingthe surgical treatment of cancer is particularly challenging becausephysicians often need to treat small, non-palpable lesions that cannotbe observed. This problem is compounded in soft tissue applicationsbecause the soft tissue is mobile and can move with respect to areference point on the patient. In the case of breast cancer, forexample, the location of a non-palpable lesion in the breast isidentified at a preoperative stage using an imaging system. The actualsurgical procedure, however, occurs in an operating room at a subsequentpoint in time, and the patient is typically in a different positionduring the surgical procedure than during the preoperative imagingstage. The breast and the lesion may accordingly be in a differentlocation relative to a reference point on the patient during thesurgical procedure than the imaging stage. The physician, therefore,generally estimates the location of lesion during surgery.

[0003] One problem with treating non-palpable lesions in soft tissues isthat the physicians may incorrectly estimate the location of thelesions. As a result, the physician may not remove all of the lesion,which is not desirable because some of the lesion will accordinglyremain in the soft tissue. Another result is that the physicians mayremove a significant amount of tissue proximate to the lesion, which cancause undesirable collateral damage to healthy tissue. Therefore, itwould be desirable to know the precise location of the lesion or othertype of target location during the surgical procedure.

[0004] A current technique for performing an excisional biopsy of anon-palpable breast lesion that has been identified by mammogram orother method involves placement of a needle or guide wire (e.g., a“Kopanz wire”), with or without blue dye, to guide the surgeon to thelesion. The tip of the needle is generally placed directly in or asclose as possible to the lesion. When larger or more complex lesions areencountered, two or more guide wires are sometimes placed at each edgeof the lesion. The entry point of the needle through the skin of thebreast is usually several centimeters from the lesion due to thelogistics of needle placement. The surgeon does not cut along the shaftof the needle from the skin because the distance is too great. Instead,the surgeon must estimate where in the breast the lesion is located bymaking reference to the location of the needle.

[0005] This technique is not optimal because it can be difficult toproperly define the margins of the tissue that is to be removed, bothduring and after insertion of the needle(s), in tissue that is amorphousand pliable (e.g., breast tissue). Also, it is often difficult for thesurgeon to detect the exact depth of the lesion based on the placementof the needles. For these reasons it is not uncommon that the biopsiedtissue does not contain the mammographically positive specimen. In othercases, as a result of the difficulty of estimating the proper locationof the boundaries of the volume of tissue to be removed, the lesion endsup being eccentrically positioned within the volume of tissue excised.This calls into question the adequacy of the margin of normal tissuesurrounding the lesion. In still other cases, more normal tissue isremoved than is required, which is disadvantageous in this era oftissue-conserving therapies.

[0006] In other fields of surgery it is known to target portions of ahuman body using various devices, and then refer to such devices inconnection with the removal or treatment of such portions. For example,U.S. Pat. No. 5,630,431 to Taylor (the “'431 patent”) describes asurgical manipulator that is controlled, in part, by informationreceived from beacons that are positioned proximate to a region of ahuman body to be treated. As another example, U.S. Pat. No. 5,397,329 toAllen (the “'329 patent”) describes fiducial implants for a human bodythat are detectable by an imaging system. The fiducial implants areimplanted beneath the skin and are spaced sufficiently from one anotherto define a plane that is detectable by the imaging system and is usedin connection with creation of images of a body portion of interest.These images are then used, for instance, in eliminating a tumor bylaser beam.

[0007] Unfortunately, the devices described in the '431 and '329 patentsare vastly more complex, and hence expensive, than is appropriate formany surgical procedures. This problem is particularly disadvantageouswith the emphasis on containing costs in managed health care.Furthermore, due to the amorphous, pliable nature of certain tissue, thesystems of the '431 and '329 patents cannot be used effectively. Systemsof the type described in the '431 and '329 patents require that thedevices (e.g., beacons or fiducial implants) defining the body portionsof interest be substantially fixed relative to one another and relativeto such body portions. These systems generally function effectively whenthe devices defining the body portion of interest are inserted in bone,e.g., in a skull in connection with brain surgery or treatment, but arenot believed to operate as intended when the devices are inserted inamorphous, pliable tissue.

[0008] Breast lesions are typically excised with a scalpel manipulateddirectly by the surgeon. With the current emphasis on surgical therapiesthat conserve breast tissue, the above-described procedure for removinga breast lesion is typically performed through a narrow opening in theskin created by slitting and then pulling apart the skin. It tends to bedifficult to manipulate the scalpel within this opening so as to removethe desired volume of tissue. The amorphous, pliable nature of breasttissue exacerbates removal of such tissue inasmuch as application offorce to the scalpel causes movement of the breast tissue relative tothe opening in the skin.

[0009] Circular cutting tools are not widely used in surgery. Recently,however, United States Surgical Corporation of Norwalk, Conn.,introduced a relatively small diameter, e.g., 5-20 mm, circular cuttingtool identified by the trademark ABBI for removing a cylinder of breasttissue for biopsy purposes. The ABBI tool includes an oscillating,motorized, circular cutting blade that incises the breast tissue. Whileuse of the ABBI tool is believed to be a relatively effective way toperform a core biopsies of breast tissue, it is not apparently designedto remove cylinders of tissue having a diameter much in excess of about20 mm. As such, it is not adapted for use in surgeries involving theremoval of relatively large tissue portions in a single cuttingsequence. In addition, the effectiveness of the ABBI tool intherapeutic, rather than diagnostic, surgeries has not been confirmed.

[0010] Detectors are used to locate organs or other portions of the bodythat have taken up a radioactive material, e.g., an antibody labeledwith a radioactive material. For example, the gamma ray probe describedin U.S. Pat. Nos. 5,170,055 and 5,246,005, both to Carroll et al., andsold by Care Wise Medical Products Corporation, Morgan Hill, Calif., andidentified by the trademark C-TRAK, provides an audio output signal, thepitch of which varies with changes in relative proximity between theprobe and a body portion that has taken up an antibody labeled with agamma ray producing material, e.g., technetium 99. Once the body portionis detected, it is removed by known surgical techniques.

[0011] Even with the systems and techniques described above, it remainsdifficult for a surgeon to remove a tissue mass in amorphous, pliabletissue, such as breast tissue, so as to ensure that the entire tissuemass is removed while at the same time conserving portions of adjacenttissue. As a result, more tissue surrounding the targeted tissue mass istypically removed than is desired.

SUMMARY

[0012] The present invention is directed toward methods, systems, andsystem components for finding a target location within a human body. Inone aspect of the invention, a system comprises a first wirelessimplantable marker configured to be implanted within the human body at alocation relative to the target location, an instrument having afunction-site and a first instrument marker connected to the instrumentat a first predetermined site relative to the function-site, a positiondetection system, and a user interface. The position detection systemcan have a sensor that detects (a) a position of the first wirelessimplantable marker relative to a reference location and (b) a positionof the first instrument marker relative to the reference location. Theposition detecting system can also include a computer that determines arelative position between the first wireless implantable marker and thefirst instrument marker based on the positions of the first wirelessmarker and the first instrument marker relative to the referencelocation. The user interface is operatively coupled to the positiondetection system. The user interface can have an indicator that denotesthe position of the function-site of the instrument relative to thetarget location based on the relative position between the firstwireless implantable marker and the first instrument marker.

[0013] In another aspect of the invention, a wireless implantable markercomprises a biocompatible casing configured to be implanted into a humanbody relative to a target location within the human body, a signalelement in the casing, and a fastener. The signal element is configuredto emit a response energy in reaction to an excitation energy. Thefastener is configured to hold the wireless marker at a referencelocation in a human body relative to the target location within thehuman body.

[0014] Yet another aspect of the invention is an instrument formanipulation within a human or proximate to the human. The instrumentcan comprise a handle, a function-site coupled to the handle, and afirst wireless instrument marker. The function-site is aligned with analignment axis, and the first wireless instrument marker can bepositioned along the alignment axis. The first wireless instrumentmarker is also configured to emit a wireless signal that can be detectedby a position detection system to determine a position of the firstwireless instrument marker relative to a reference location.

[0015] The systems and components can be used in many applications inwhich it is desirable to accurately know the relative position betweenan instrument and a target location within a human body. For example,one embodiment of a method of treating a target location within a humanbody comprises exciting a wireless marker implanted in the body byemitting an excitation energy in a manner that causes the marker to emita response energy. The method can continue by sensing the responseenergy and determining a position of the wireless marker relative to areference location based on the sensed response energy. In otheraspects, the method can also include determining a position of aninstrument with a marker relative to the reference location, anddisplaying the relative position between the instrument and the targetlocation. Other aspects of the invention are described in the followingdetailed description of the invention and the claims, and theaccompanying drawings illustrate several embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016]FIG. 1 is an isometric view representative of a tissue mass andsurrounding tissue volume that is bracketed by the markers, with twomarkers being positioned on opposite ends of each of mutually orthogonalX, Y and Z-axes intersecting the tissue mass so as to define theboundary of the tissue volume, and with the probe and detector beingpositioned adjacent the tissue volume in accordance with one embodimentof the invention.

[0017]FIG. 1A is an isometric view of the tissue mass illustrated inFIG. 1, with two markers being positioned on opposite ends of each ofmutually orthogonal X1, Y1 and Z-axes and with two markers beingpositioned on opposite ends of mutually orthogonal X2 and Y2-axes whichare mutually orthogonal with respect to the Z-axis and offset along withZ-axis with respect to the X1 and Y1-axes.

[0018]FIG. 1B is an isometric view of the tissue volume illustrated inFIG. 1, with two markers being positioned on opposite ends of each of V,W, X and Y-axes, all of which lie in a common plane and are mutuallyorthogonal with respect to a Z-axis, all of these axes intersecting thetissue mass.

[0019]FIGS. 2a-2 g are schematic representations of various embodimentsof the markers of the present invention and their associated detectioncharacteristics.

[0020]FIG. 3a is a block diagram of the elements of one embodiment ofthe marker illustrated in FIG. 2c.

[0021]FIG. 3b is a block diagram of the RF exciter used with the markerillustrated in FIG. 3a.

[0022]FIG. 4 is a block diagram of the elements of one embodiment of themarker illustrated in FIG. 2e.

[0023]FIG. 5 is a block diagram of the RF exciter used with the markerillustrated in FIG. 4.

[0024]FIG. 6 is a perspective view of one embodiment of the markerillustrated in FIG. 2F, with details of internal construction beingillustrated in phantom view.

[0025]FIG. 7 is a block diagram of the probe and detector used with themarker illustrated in FIG. 2b.

[0026]FIG. 8 is a block diagram of the probe and detector used with themarker illustrated in FIG. 2c.

[0027]FIG. 9 is a front elevation view of a tissue anchor in accordancewith one embodiment of the invention, with the cannula and rod of thecutter being shown in broken view to facilitate illustration.

[0028]FIG. 10 is an enlarged view of the tissue anchor in FIG. 9, withthe rod and cannula both being broken at first location and the rodalone being broken at a second location to facilitate illustration, alsowith the rod being shown in a retracted position relative to thecannula.

[0029]FIG. 11 is similar to FIG. 10, except that the rod is shown in theextended position relative to the cannula, with the anchor membersattached to the end of the rod being shown in an extended positionengaged in a portion of a tissue mass.

[0030]FIG. 12 is a top view of a breast of woman in a supine position,with a tissue mass being surrounded by markers of one embodiment of thepresent invention so as to define the tissue volume to be removed, andwith an incision formed in the skin of the breast above the tissuevolume.

[0031]FIG. 13 is a cross-sectional view of the breast of FIG. 12 takenalong line 13-13 in FIG. 12.

[0032]FIG. 14 is similar to FIG. 12, except that the skin adjacent theincision has been pulled apart to provide access to underlying breasttissue.

[0033]FIG. 15 is an enlarged view of the incision of FIG. 14, with thetissue anchor illustrated in FIGS. 9-11 being positioned in the tissuemass, and the two portions of a cutter illustrated being positionedadjacent the surgical cavity.

[0034]FIG. 16 is similar to FIG. 13, except that an incision has beenformed in the skin of the breast and retracted to provide access to theunderlying tissue mass to be removed and the tissue anchor has beenpositioned above the breast.

[0035]FIG. 17 is an enlarged view of the portion of the breastillustrated in FIG. 16 containing the tissue mass to be removed, withthe tissue anchor being positioned in the tissue mass in the extendedposition so that the anchor members of the tissue anchor engage thetissue mass.

[0036]FIG. 18 is similar to FIG. 15, except that two portions of acutter are illustrated in engaged, cooperative relationship and arepositioned under the skin in contact with the tissue volume to beremoved.

[0037]FIG. 19 is similar to FIG. 16, except that the tissue cutter isillustrated surrounding the tissue anchor and in cutting engagement withthe tissue volume to be removed.

[0038]FIG. 20 is similar to FIG. 19, except that the tissue volume hasbeen completely removed from the breast and is illustrated immediatelyabove the surgical opening in engagement with the tissue anchor andcutter.

[0039]FIG. 21 is an isometric view of a system for locating and defininga target location within a human body in accordance with an embodimentof the invention.

[0040]FIG. 22 is a schematic elevation view illustrating a portion of asystem for locating and defining a target location within a human body.

[0041] FIGS. 23A-D are isometric cut-away views of wireless resonatingmarkers in accordance with embodiments of the invention.

[0042] FIGS. 24-30 are side elevation views of several wirelessimplantable markers in accordance with embodiments of the invention.

[0043] FIGS. 31-33 are side elevation views of several wirelessimplantable markers in accordance with additional embodiments of theinvention.

[0044] FIGS. 34-39 are isometric views of arrangements for implantingthe wireless implantable markers relative to a target location T inaccordance with embodiments of the invention.

[0045] FIGS. 40-43 are side cut-away views of instruments in accordancewith embodiments of the invention.

[0046]FIGS. 44 and 45 are schematic views of wireless controls forinstruments in accordance with embodiments of the invention.

[0047] FIGS. 46-52 are isometric views illustrating several instrumentsin accordance with various embodiments of the invention.

[0048]FIG. 53 is a partially schematic view illustrating an aspect ofoperating a system for locating and defining a target location within ahuman body in accordance with an embodiment of the invention.

[0049]FIG. 54A is a front elevation view of an embodiment of a userinterface in accordance with the invention.

[0050]FIG. 54B is a graphical representation of calibrating a displaycoordinate system.

[0051] FIGS. 55-57 are front elevation views of several embodiments ofuser interfaces in accordance with various embodiments of the invention.

[0052] FIGS. 58A-58C are front elevation views of an embodiment of auser interface illustrating a method of operating the system inaccordance with an embodiment of the invention.

[0053] FIGS. 59-61 are front elevation views of several additional userinterfaces in accordance with more embodiments of the invention.

DETAILED DESCRIPTION

[0054] The following description is directed toward systems and methodsfor locating and defining a target location within a human body. Severalaspects of one system in accordance with an embodiment of the inventiondirected toward bracketing a target location with at least one markerare described below in Section I. Similarly, aspects of other systems inaccordance with embodiments of the invention directed toward locating atarget mass within a human body using the relative orientation betweenan implanted marker and an instrument are described below in Section II.Other aspects of embodiments of the invention directed toward definingand displaying a virtual boundary relative to a target location based onthe location of an implanted marker are also described below in SectionII.

[0055] I. Systems and Methods for Delineating a Target Location UsingBracketing

[0056] FIGS. 1-20 illustrate a system and several components fordelineating a target location within a human body in accordance withseveral embodiments of invention. Several of the components describedbelow with reference to FIGS. 1-20 can also be used in the systems setforth with respect to FIGS. 21-61. Therefore, like reference numbersrefer to like components and features throughout the various figures.

[0057] Referring to FIG. 1, one aspect of the present invention is asystem 20 for defining the boundaries of, i.e., bracketing, a tissuevolume 22 in a tissue portion 24. Typically, tissue volume 22 willinclude a tissue mass 26, e.g., a breast lesion, that is targeted forremoval and a tissue margin 28 of unaffected tissue surrounding thetissue mass. After tissue volume 22 is bracketed, system 20 can be usedto locate the defined boundaries of the tissue volume, e.g., inconnection with the surgical removal of tissue mass 26. It will beappreciated that the invention can have other applications includingradiation therapy, colo-rectal treatments, and many other applicationsin which it is useful to locate a target location other than a tissuevolume within a human body.

[0058] As described in more detail below, other aspects of the presentinvention are also directed to a method of bracketing tissue volume 22using system 20, and a method of removing tissue volume 22 using system20. These methods can be accomplished with other aspects of the presentinvention, such as markers, instruments, stabilizers/anchors, positiondetection systems and user interfaces described below.

[0059] System 20 comprises a plurality of markers 30, a probe 32 and adetector 34 connected to the probe. As described in more detail below,markers 30 are implanted in tissue portion 24 under the guidance of aconventional imaging system not forming part of the present invention,so as to bracket tissue volume 22. Such imaging systems may includeultrasound, magnetic resonance imaging (“MRI”), computer-aidedtomography (“CAT”) scan, and X-ray systems. Markers 30 are imageablewith the imaging energy generated by the imaging system. For example, ifan ultrasound imaging system is used to implant markers 30, the latterare configured and made from a material that strongly reflectsultrasound energy. Materials that are imageable with the energygenerated by such systems are well known to those skilled in the art,and so are not described in detail here. Following implantation ofmarkers 30, probe 32 and detector 34 are used to locate the markers, asdescribed in more detail below.

[0060] The terms “probe 32” and “detector 34” are used genericallyherein to refer to all embodiments of the probe and detector describedbelow. Specific embodiments of the probe 32 and detector 34 areidentified using a prime notation described below, i.e., probe 32′ ordetector 34″. Additionally, the probes described below define one typeof instrument, and the detectors described below define one type ofposition detection system in accordance with embodiments of theinvention.

[0061] A. Markers

[0062] The markers 30 can be biologically inert (biocompatible) and arerelatively small so that they do not impair procedures for removing ortreating a tissue volume 22. Markers 30 may have different geometricconfigurations, e.g., spherical, disk-like, cylindrical, and othershapes. In one particular embodiment, the greatest dimension of a marker30 measured along a Y-axis extending through the marker from one surfaceto an opposite surface is not more than about 5 mm. The markers 30 canbe even smaller, e.g., the greatest dimension is about 1-2 mm, or theycan also be larger. Although several of the markers with respect toFIGS. 2-8 are described in connection with this aspect of the invention,they can also be used in connection with other aspects.

[0063] In addition, markers 30 each have a detection characteristic toenable detection by probe 32 and detector 34, or by a separate detectionsystem with an array of sensors relative to a reference location. Thedetection characteristics of the various embodiments of markers 30 canbe characterized as active or passive. In the active category, thedetection characteristic of a first embodiment of marker 30, illustratedin FIG. 2a as marker 30 a, is gamma radiation 40. In this regard, marker30 a may include materials such as technetium 99, cobalt isotopes oriodine isotopes. Such materials may be obtained from DuPont ofBillerica, Mass. Preferably, each marker 30 a generates gamma radiation40 having a field strength in the range of 1-100 microCuries.

[0064] Also in the active category, in a second embodiment of marker 30,illustrated in FIG. 2b as marker 30 b, the detection characteristic ismagnetic field 42. Markers 30 b of the second embodiment thus containferromagnetic materials in which a magnetic field can be induced, oralternatively are permanently magnetized and so have an associatedpermanent magnetic field. In FIG. 2b, magnetic field 42 represents boththe induced and inherent magnetic fields. Strong permanent magnets, suchas those made from Samarium-Cobalt, can be suitable magnets for markers30 b. Alternatively, the markers may communicate with the positiondetection system by resonating markers (e.g., AC magnetic coupling usingcoils of wire as receiving and emitting antenna), as described belowwith reference to FIGS. 23A-D.

[0065] Referring to FIG. 2c, in a third embodiment, again in the activecategory, marker 30 c emits radio frequency (“RF”) signal 44 in responseto a triggering signal 46. Various energy sources may be used fortriggering signal 46, including a magnetic field, ultrasound or radiofrequency energy. In this latter case, marker 30 c is preferablydesigned to receive triggering signal 46 which has a first RFwavelength, and in response thereto, emit signal 44 of a second RFwavelength. In the simplest case, no data, other than the specific radiofrequency itself, is carried in signal 44. Alternatively, markers 30 cmay all transmit signal 44 at a single frequency, with data uniquelyidentifying each marker being carried in signal 44 emitted by eachmarker.

[0066] A suitable marker 30 c is illustrated in FIG. 3a. This marker 30c includes a transmit/receive antenna 52 for receiving an RF signal at afirst frequency and transmitting an RF signal at a second frequency.Also included is a power detect/regulate circuit 54 connected to antenna52 that detects the presence of, and regulates, the RF signal receivedby the antenna. The regulated RF signal is provided from circuit 54 todrive radio frequency generator 56 which generates an RF signal at asecond frequency. As discussed in more detail below, when multiplemarkers 30 c are used together in a given bracketing procedure,preferably each marker transmits RF signals at a second frequency whichis unique to the marker. The frequency of the received RF signal 46,however, is preferably common with respect to all of the markers 30 cused in the bracketing procedure. The RF signal generated by radiofrequency generator 56 is then provided to antenna 52 where it istransmitted as an RF signal.

[0067] Referring to FIG. 3b, an RF exciter device 60 for generating RFsignal 46 is illustrated. RF exciter 60 includes a radio frequencygenerator 62 for generating RF signal 46 at a predetermined frequencyand an RF amplifier 64 for amplifying the output from the radiofrequency generator. The sensitivity of amplifier 64 may be controlledusing gain adjustment 62 coupled to the amplifier. The output of RFamplifier 64 is provided to transmit antenna 68 which transmits RFsignal 46. Transmit antenna 68 of RF exciter 60 is preferably placed inrelatively close proximity to marker 30 c, with appropriate gainadjustment of RF amplifier 64 being achieved by control gain adjustment66 until a suitable return signal is absorbed from detector 34″,discussed below and illustrated in FIG. 8.

[0068] In a fourth embodiment, again in the active category, marker 30d, illustrated in FIG. 2d, continuously emits signal 44 at specificfrequencies in the radio frequency spectrum. The marker 30 c illustratedin FIG. 3A and described above can be satisfactorily employed as marker30 d by adding a battery (not shown) in place of power detector portionof circuit 54 of marker 30 c. RF exciter 60 is not required inconnection with marker 30 d, insofar as the battery generates the energyused by the marker in producing RF signal 44. The embodiments of the RFMarkers are one example of a resonating marker having an electricalcircuit in accordance with an embodiment of a wireless implantablemarker.

[0069] As a fifth embodiment in the active category, marker 30 e,illustrated in FIG. 2e, is designed to vibrate following implantation.This vibration is a detection characteristic that is chosen to enhanceimage contrast when marker 30 is intended to be detected using a probe32 and detector 34 that perform ultrasound imaging. More specifically,incoming ultrasound signal 74 is reflected off marker 30 e as reflectedultrasound signal 76, with a Doppler shift component being added to thereflected signal due to the vibration of the marker to enhanceimageability of the marker. The vibration frequency of marker 30 e willvary depending upon the frequency of ultrasound energy generated byprobe 32, but is preferably lower than the frequency of incomingultrasound signal 74 which is typically 7.5 MHz, i.e., the vibrationfrequency is preferably in the 50 Hz to 50 kHz range. This embodiment isan example of a mechanical resonating marker in accordance with anotherembodiment of a wireless implantable marker.

[0070] A suitable marker 30 e that achieves the functionality describedabove is illustrated in FIG. 4. This marker 30 e includes an antenna 80for receiving an RF signal that provides the energy driving the marker.A power detection and regulation circuit 82 is connected to antenna 80for detecting when the antenna is receiving an RF signal and forregulating the signal for use by oscillator and waveform generatorcircuit 84 connected to circuit 82. Circuit 84 converts the regulated RFsignal received from circuit 82 into an oscillating electrical signal,preferably in the audio frequency range (i.e., 20 Hz-20 kHz), having awaveform that is optimized to drive piezoelectric device 86 connected tocircuit 84. Piezoelectric device 86 is a conventional piezoelectricdevice of the type that converts an oscillating electrical input signalinto mechanical oscillations. Piezoelectric device 86 is attached viasupport 88 to outer housing 90 of marker 30 e. Housing 90 is designed toresonate at the mechanical oscillation frequency of piezoelectric device86.

[0071] Referring to FIG. 5, an RF coupled acoustic exciter 92 isprovided for generating the RF signal received by antenna 80 of marker30 e. Exciter 92 includes a radio frequency generator 94 for generatingan RF signal. RF amp 96, with a gain adjustment 98 connected thereto, isprovided for receiving and amplifying the output signal from generator94. A transmit antenna 100 is provided for receiving the output of amp96 and transmitting the RF signal used to drive marker 30 e. In use,gain 98 of amp 96 is adjusted to amplify the RF signal produced bygenerator 94 such that marker 30 e is caused to mechanically oscillateso it is most clearly observable by the ultrasound imaging system (notshown) used in conjunction with marker 30 e.

[0072] As those skilled in the art will appreciate, other circuitconfigurations may be used in marker 30 e to cause piezoelectric device86 to vibrate. For example, a frequency divider circuit (not shown) maybe used in place of oscillator/waveform generator circuit 84. With suchalternative, exciter 92 is modified to include a variable frequencyoscillator (not shown) in place of radio frequency generator 94.

[0073] In the passive category, the detection characteristic in a sixthembodiment of marker 30, illustrated as marker 30 f in FIG. 2f, isopacity to incoming ultrasound signal 74. That is, marker 30 f reflectsincoming sound energy sufficiently to create a strong image in reflectedsignal 76 so as to enhance imageability using a conventional ultrasoundimaging system. In many cases, it will be advantageous to incorporatethe detection characteristics of marker 30 f in marker 30 e.

[0074] While those skilled in the art are familiar with materials andconfigurations that can be used for marker 30 f, one suitable marker 30f is illustrated in FIG. 6. This marker 30 f includes plate 102, plate104 and plate 106, all of which are preferably arranged in mutuallyorthogonal relationship. It is preferred that each of the plates 102-106has a square configuration and the length of each edge of the plates,e.g., the length of edge 108 of plate 104, is preferably about twice thewavelength of incoming ultrasound signal 74. For example, when incomingultrasound signal 74 has a wavelength of 7.5 MHz, edge 108 has a lengthof about 2 mm. Plates 102-106 are made from a material that stronglyreflects ultrasound energy, e.g., aluminum, and typically have athickness in the range of 10-100 μm. Plates 102-106 ideally are enclosedin a biologically non-reactive casing 110. The latter is preferably madefrom a material that does not have strong ultrasound reflectioncharacteristics, e.g., a soft polymer.

[0075] Also in the passive category, marker 30 g of the seventhembodiment, illustrated in FIG. 2g, comprises a capsule (not shown)filled with a colored dye 78, e.g., a vital dye. Either or both thecapsule and dye 78 of marker 30 g are made from a material that isimageable by the imaging system, e.g., ultrasound, used to implant themarkers, as described in more detail below. The capsule is made fromgelatin or other suitable material that is selected to be sufficientlytough to withstand insertion into tissue volume 22, but is relativelyeasily cut by the cutting tool used to remove the tissue volume, e.g., aconventional surgical scalpel or cutting tool 200 described below.Marker 30 g provides a visual guide as to its location by releasingcolored dye 78 when severed by a surgical cutting tool. In this regard,probe 32 and detector 34 are not used in connection with marker 30 g.

[0076] Markers 30 a, 30 b and 30 f may be made from a solid structurecontaining material having the desired detection characteristic.Alternatively, markers 30 a, 30 b and 30 f may be made from a capsulefilled with a dye, such as is used for marker 30 g, containing materialhaving the desired detection characteristic. As another alternative, allembodiments of markers 30 may include a dye contained in an outercapsule having the requisite toughness and severability characteristicsnoted above.

[0077] B. Probe and Detector

[0078] The probe 32 shown in FIG. 1 is one embodiment of an instrument,and the detector 34 shown in FIG. 1 is one embodiment of a userinterface for any system in accordance with the invention. The designand configuration of the probe 32 and the detector 34 depend upon theembodiment of marker 30 used. However, for all embodiments of marker 30(except marker 30 g), detector 34 is designed to provide humanlyrecognizable information when probe 32 is positioned within a selectedproximity, e.g., 1-5 cm, of a given marker. This information may takeone of a variety of forms, including a burst of humanly perceivablesound, constant or intermittent illumination of a light, movement of aneedle on a dial, a short burst of air, change of data in a visualdisplay, increased image brightness or contrast (in the case whendetector 34 is an ultrasound imaging system, as discussed below), atactile response, or other humanly perceivable proximity information. Inthis regard detector 34 may include a dial 112, light 114, speaker 116,or other appropriate devices for generating the selected form of humanlyperceivable information.

[0079] Preferably, although not necessarily, detector 34 provideshumanly recognizable information that indicates changes in proximity ofprobe 32 to a given marker 30. Thus, rather than merely providing staticor threshold information that probe 32 is within a predetermined rangeof a given marker 30, detector 34 preferably provides proximityinformation having an attribute or characteristic that varies as afunction of changes in proximity of the probe relative to the marker.For example, if the proximity information is sound, the pitch is variedwith changes in proximity. Or, as another example, if the proximityinformation is light, the brightness of the light changes with changesin proximity.

[0080] A probe and detector that may be satisfactorily employed as probe32 and detector 34, respectively, when the latter is intended to detectmaker 30 a, is sold by Care Wise Medical Products Corporation of MorganHill, Calif., and is identified by the trademark C-TRAK. The C-TRAKprobe, which is described in U.S. Pat. Nos. 5,170,055 and 5,246,005 toCarroll et al., which are incorporated herein by reference, provides ahumanly audible sound, the pitch of which varies with changes inproximity of the probe to tissue labeled with gamma ray producingmaterial.

[0081] Referring to FIGS. 1, 2b and 7, when probe 32 and detector 34 areintended for use in detecting marker 30 b, which generates a magneticfield 42, probe 32′ and detector 34′ illustrated in FIG. 7 may besatisfactorily employed. Probe 32′ includes a conventional Hall effectsensor (not shown) that provides an output signal on line 120, thevoltage of which varies as a function of proximity of the probe to themagnetic field generated by a marker 30 b. Detector 34′ is connected toprobe 32′ via line 120, and includes an amplifier 122 connected to line120 for amplifying the signal from the Hall effect sensor in probe 32′.Amplifier 122 includes an offset adjustment 126 and a gain adjustment128. Offset adjustment 126 is provided to cancel the effects of anyambient magnetic fields, such as that of the earth. Gain adjustment 128is provided to control the overall sensitivity of detector 34′. Theamplified signal from amplifier 122 is delivered on line 124 to signalmeter 126, which may comprise a dial with a movable needle, an LED orother device for representing signal strength. Also connected to line124 is voltage-controlled oscillator 128, the output of which isprovided to amplifier 130. The output of amplifier 130 drives speaker116. The frequency of the output signal from voltage controlledoscillator 128 varies as function of changes in voltage of the signaldelivered on line 124, which in turn causes the pitch of the soundproduced by speaker 116 to vary as a function of changes in the voltageof the signal on line 124. As those of ordinary skill in the art willappreciate, other devices for providing humanly recognizable informationrepresenting changing proximity, e.g., a light, may be employed insteadof speaker 116.

[0082] Referring to FIGS. 1, 2c and 8, for markers 30 c and 30 d, whichgenerate radio frequency energy, probe 32″ and detector 34″ are providedfor use in detecting the markers. Probe 32″ includes a conventional coilantenna 140 for receiving an RF signal. Detector 34″ includes aselectable notch filter 142 connected to antenna 140 which permitstuning of the detector to the unique RF frequency of signal 44 emittedby markers 30 c or 30 d. A tuning knob or other user adjustablemechanism (neither shown) is attached to selectable notch filter 142 topermit a user to perform such tuning. The output of selectable notchfilter 142 is provided to RF amplifier 144, the overall sensitivity ofwhich may be controlled by gain adjustment 146 attached to theamplifier. The output of RF amplifier 144 is provided torectifier/integrator circuit 148 which rectifies and time filters thesignal. The output of rectifier/integrator circuit 148 is provided toanalog signal strength display 150 which provides a visual indication ofthe proximity of probe 32″ to marker 30 c. In addition, the output ofrectifier/integrator circuit 148 is provided to voltage oscillator 152which generates an output signal, the frequency of which varies as afunction of the voltage level of the signal provided byrectifier/integrator circuit 148. The output signal of the voltagecontrol oscillator 152 is amplified by audio amplifier 154, which inturn drives speaker 116. Accordingly, the pitch of the sound generatedby speaker 116 varies as a function of the strength of the RF signalreceived by probe 32″, and hence as a function of the proximity of probe32″ to markers 30 c or 30 d.

[0083] A suitable probe 32 and detector 34 for use with the markers 30 eand 30 f is the ultrasound imaging system available from DornierSurgical Products, Inc., Phoenix, Ariz., is identified by the namePerforma, and generates ultrasound energy having a frequency of 7.5 MHz.

[0084] C. Tissue Anchor

[0085] Turning now to FIGS. 9-11, another aspect of the presentinvention is tissue anchor 300. The latter is designed to stabilizetissue mass 26 during surgical removal of the mass using system 20, asdescribed in more detail below.

[0086] Tissue anchor 300 includes a ring 302 sized to receive the thumbor finger of a user, and a rod 304. The latter includes a proximal end305, which is attached to ring 302, and a distal end 306. Rod 304includes an outwardly projecting pin 308 that serves as a stop, asdescribed below. Tissue anchor 300 also includes a plurality of, e.g.,four, anchor members 310 that are attached to rod 304 at or adjacent itsdistal end 306. Typically, anchor members 310 are attached to rod 304 soas to extend away from its distal end 306, as illustrated in FIGS. 9 and10. However, as an alternative design, anchor member 310 may be attachedto rod 304 so as to extend away from distal end 306 toward proximal end305 (not shown). Each anchor member 310 may terminate with a barb 312(FIG. 11), if desired. Anchor members 310 preferably have a curvedconfiguration when in an unbiased state, as illustrated in FIGS. 9 and11. Anchor members 310 are preferably made from spring steel, althoughother “memory” metal alloys made also be satisfactorily used. In certainapplications it may be unnecessary to provide a curve in anchor member310, i.e., the anchor member may be substantially straight.

[0087] Rod 304 preferably, although not necessarily, has a circularcross section. The outside diameter of rod 304 depends upon its intendedapplication, but is typically in the range of 0.3-10 mm, preferablyabout 1-2 mm. The length of rod 304, as measured between proximal end305 and distal end 306, also depends upon its desired application, buttypically ranges from 5-20 cm.

[0088] Tissue anchor 300 also includes a cannula 320 having a centralbore 322, a proximal end 324 and a pointed distal end 326. Central bore322 has an inside diameter that is sized to receive rod 304 with a closesliding fit. Cannula 320 has an outside diameter that is selected basedon the intended application but is typically in the range 0.5 mm-12 mm,preferably about 1-3 mm. Cannula 320 also includes an elongate slot 328that runs parallel to the long axis of the cannula and is sized toreceive pin 308 with a close sliding fit. The length of slot 328 issubstantially the same as the length of anchor members 310. Slot 328includes a pocket 329 at its end closest to distal end 326 of cannula320 that extends orthogonally to the long axis of the slot and is sizedto receive pin 308.

[0089] Cannula 320 also includes a plurality of apertures 330 extendingthrough the wall of the cannula. Apertures 330 are positioned adjacentdistal end 326 of cannula 320 when anchor members 310 are attached torod 304 to extend away from distal end 306 as illustrated in FIGS. 10and 11. If anchor members 310 extend from distal end 306 toward proximalend 305 (not shown), then apertures 330 are moved toward the proximalend so that they are spaced from the distal end 326 at least about thelength of the anchor members. One aperture 330 is typically provided foreach anchor member 310. The lengths of anchor members 310, cannula 320,and slot 328 are together selected so that a small portion, e.g., about1 mm, of each anchor member 310 projects from its respective aperture330 when tissue anchor 300 is in the retracted position illustrated inFIG. 10. In this position, pin 308 engages the end of slot 328 closestto proximal end 324. Anchor members 310 are sized in this manner toensure the anchor members remain positioned in their respectiveapertures 330 when tissue anchor 300 is in the retracted positionillustrated in FIG. 10.

[0090] The lengths of anchor members 310, cannula 320, and slot 328 arealso together selected so that most, if not substantially the entire,length of the anchor members 310 projects from their respectiveapertures 330 when tissue anchor is in the extended position illustratedin FIGS. 9 and 11. In this position, pin 308 engages the end of slot 328closest to distal end 326.

[0091] The elements of tissue anchor 300 are preferably made fromstainless steel, a plastic such as polystyrene or polyurethane, or othermaterials suitable for the intended application of the tissue anchor (asdescribed in more detail below) known to those skilled in the art. Asnoted above, in many cases it is desirable to make anchor members 310from spring steel or a “memory” metal alloy.

[0092] D. Bracketing

[0093] Referring now to FIGS. 1, 12 and 13, markers 30 may be used tobracket (i.e., define the boundaries of) tissue volume 22 in a tissueportion 24 in accordance with the following method. In the followingdescription of the method of bracketing tissue volume 22, the latter iscontained in a human breast. However, it is to be appreciated thattissue volume 22 may be present in other hollow or solid organs andstructures, e.g., a liver, or may constitute an entire organ orstructure. Additionally, a plurality of the markers 30 may be implantedto completely bracket the tissue volume 22, or one or more markers 30can be used to bracket or otherwise mark the location of the tissuevolume 22.

[0094] As the first step in bracketing tissue volume 22, a tissue mass26 of interest is identified through conventional imaging methods, e.g.,ultrasound, MRI, X-ray or CAT scan. Next, markers 30 are implanted intissue portion 24 surrounding tissue mass 26 and defining outerboundaries of tissue volume 22. The number of markers 30 used, and theplacement of the markers relative to tissue mass 26, will vary dependingupon the location of the tissue mass relative to other types of tissue,e.g., bone or muscle, surgeon preference, size and configuration of thetissue mass and the desired amount of tissue margin 28 (FIG. 1) beyondthe edge of tissue mass 26. However, in many applications, it may bedesirable to use at least six markers 30 to bracket tissue volume 22,preferably two on each of axes X, Y and Z (see, e.g., FIGS. 1, 12 and13). Two of the markers 30 can be positioned on each of axes X, Y and Zso as to lie on opposite boundaries of tissue volume 22. For example, asillustrated in FIG. 1, marker 30, lies on the Z-axis at the uppersurface of tissue volume 22, marker 302 lies on the Z-axis at the lowersurface of the tissue volume, marker 303 lies on the X-axis at a firstlocation on the outer surface of the tissue volume, marker 304 lies onthe X-axis at a second location on the outer surface of the tissuevolume diametrically opposite marker 303, marker 305 lies on the Y-axisat a third location on the outer surface of the tissue volume, andmarker 306 lies on the Y-axis at a fourth location on the outer surfaceof the tissue volume diametrically opposite marker 305.

[0095] Although the axes X, Y and Z can be mutually orthogonal, asillustrated, this is not mandatory and can be difficult to preciselyimplement in practice. In this particular embodiment, the tissue volume22 should be completely surrounded by markers 30, i.e., the tissuevolume should be defined in three dimensions by the markers. One notableexception to this that the marker 30, such as marker 302 shown in FIGS.1 and 13, positioned at the base of, i.e., underneath, tissue volume 22is not typically required when a different type of tissue, such aspectoral muscle 400 (FIG. 13) is located at or near where the markerwould be positioned. The illustration of marker 302 in FIG. 13 is notinconsistent with this recommended placement regime for markers 30because of the relatively great spacing between the marker 302 andpectoral muscle 400. Similarly, when the marker 30, such as marker 30,shown in FIG. 1, to be positioned on top of tissue volume 22 is near theskin overlying the tissue volume, such marker is not typically required.Also, while the X, Y and Z-axes are illustrated in FIG. 1 asintersecting at a common point centrally located within tissue mass 26,this is not required. For example, it may be desirable to offset the Xand Y-axes somewhat, as measured along the Z-axis. Furthermore, in somecases it may be desirable to define tissue volume 22 with markers 30 inonly two dimensions or in only one dimension.

[0096] In some cases, it will be desirable to use more than two markers30 on X, Y and Z-axes. Referring to FIG. 1A, in a first case, tenmarkers 30 are used, two on the Z-axis, two on an axis X₁, two on anaxis X₂ that is offset along the Z-axis with respect to axis X₁, two onan axis Y₁, and two on an axis Y₂ that is offset along the Z-axis withrespect to axis Y₁. Referring to FIG. 1B, in a second case, ten markers30 are used, two on the X-axis, two on the Y-axis, two on the Z-axis,two on the V-axis which bisects the X and Y-axes and two on the W-axiswhich also bisects the X and Y-axes, but at a different location. Othernumbers and relative placements of markers are also encompassed by thepresent invention.

[0097] Markers 30 are preferably spaced from tissue mass 26 so as todefine tissue volume 22 such that tissue margin 28 is large enough toensure none of the tissue mass of interest lies outside the tissuevolume. This precise spacing will vary with the nature of the tissuemass 26, the size of the tissue mass, surgeon preference and otherfactors. However, tissue margin 28, as measured outwardly along an axisextending perpendicular to a surface location on tissue mass 26, isgenerally about 0.5 cm to 3 cm, and is preferably about 1 cm to 2 cm. Itwill be appreciated that other margins may be more appropriate in othercircumstances.

[0098] Markers 30 may be implanted in tissue portion 24 in a variety ofdifferent ways using a variety of different tools. In general, markers30 are implanted using a conventional imaging system (not shown) thatsimultaneously generates an image of tissue mass 26 and the markers. Byfrequently comparing the location of markers 30 to tissue mass 26 duringimplantation of the markers into tissue portion 24, based on imageinformation received from the imaging system, the markers may bepositioned so as to define tissue volume 22 in the manner describedabove. As noted above, markers 30 are made from a material that providesgood image contrast with respect to the imaging energy used. In otheraspects of the invention, only one or two markers may be implanted in orproximate to the tissue mass 26, and the margin 28 can be defined on adisplay by a virtual line or shape based upon the relative locationbetween at least one of the implanted markers and the tissue mass 26.

[0099] It is preferable to at least partially immobilize tissue portion24 during implantation of markers 30. However, this is not necessarybecause, by comparing the relative location of a marker 30 to tissuemass 26, the desired relative placement can typically be achieved evenif tissue portion 24 is moving during marker implantation.

[0100] E. Marker Implantation

[0101] Various techniques may be used to implant markers 30 in tissueportion 24. With reference to FIGS. 12 and 13, one approach is to insertmarkers 30 percutaneously through skin 402 overlying tissue portion 24using known needle pushers or implanters (neither shown) of the typeused to implant “seeds” of radioactive material for various cancertreatments. For example, needle pushers of the type sold by BestIndustries of Springfield, Va., may be satisfactorily employed. Theseneedle pushers include a central needle surrounded by an outer tubehaving an end plate or cup for supporting the radioactive “seed.”Following insertion of the needle pusher into the selected tissue mass,the radioactive “seed” is released by pressing the central needledownwardly relative to the surrounding outer tube, with the point of theneedle ejecting the “seed” from the end plate or cup of the outer tube.

[0102] To percutaneously insert marker 30 in accordance with this firstapproach, the marker is positioned on the end of the needle pusher (inplace of the radioactive “seed”), is forced through skin 402 and, usingfeedback from the imaging system, is guided to the region where it isdesired to implant the marker. Then the marker 30 is ejected from theneedle pusher by urging the central needle forwardly into the innertube.

[0103] A second approach for implanting markers 30 involves creating asmall, e.g., 5-10 mm, incision (not shown) in the skin 402 overlyingtissue portion 24. Next, a scalpel is inserted through the incision soas to form a slit in the underlying tissue portion extending to theposition where it is desired to implant a maker 30. Then a marker 30 isinserted through the slit to such position using a tweezers, needlepusher, trocar or other suitable tool. Other markers 30 are implantedthrough separate incisions in skin 402 in similar manner so as tobracket tissue volume 22.

[0104] Referring now to FIGS. 1 and 12-14, a third approach forimplanting markers 30 is to form a relatively large, e.g., 1-3 cm,incision 404 (see FIG. 12) in skin 402 overlying tissue mass 26. Next,incision 404 is pulled open as illustrated in FIG. 14 using retractorsor other conventional devices to form a relatively large open region 406above tissue mass 26. Markers 30 are then implanted into tissue portion24 using either the first or second approaches described above. Otherapproaches for implanting markers 30 so as to bracket tissue mass 26 arealso encompassed by the present invention. The speed and accuracy withwhich markers 30 may be implanted, and the trauma associated withimplantation should be considered in selecting other approaches forimplanting markers 30.

[0105] F. Marker Identification

[0106] Once tissue mass 26 has been bracketed or otherwise marked,tissue volume 22 can be removed. As described in more detail below, oneprocedure involves identifying the boundaries of tissue volume 22 usingan embodiment of probe 32 and detector 34 that is appropriate for thetype of marker 30 used, as discussed above. Using information fromdetector 34 regarding such boundaries, tissue volume 22 is then removedusing a scalpel or other tool, with tissue anchor 300 preferably, butnot necessarily, being used to stabilize the tissue volume duringremoval. Another procedure is similar to the first, except that tissueanchor 300 is not used.

[0107] For both of these procedures, as the first step the surgeontypically identifies the boundaries of the tissue volume using system 20or otherwise marks the location of the tissue mass 26 as described inmore detail below. This step is generally needed because in practicemarkers 30 will often be implanted by another doctor, e.g., aradiologist, as a separate procedure. The boundaries of tissue volume 22are identified by moving probe 32 in the general region of the tissuevolume and then monitoring the detection information (e.g., sound,light, dial movement, image clarity and the like) provided by detector34. As noted above, detector 34 may provide this information when probe32 is moved within a predetermined proximity of a given marker 30, ormay provide this information in a form that changes with changes inproximity of the probe to the marker (e.g., a light gets brighter as theprobe is moved toward a marker and dimmer as it is moved away).

[0108] The interaction between marker 30 and probe 32 and detector 34depends upon the detection characteristic of the marker. In the case ofmarker 30 a, which emits gamma radiation 40 (FIG. 2a) on a continuousbasis, a probe and detector of the type described in U.S. Pat. Nos.5,170,055 and 5,246,005 to Carroll et al. (the “C-TRAK probe”), asdiscussed above, may be satisfactorily used to detect the markers. TheC-TRAK probe includes a radiation detector, e.g., a scintillationcrystal, which provides an output signal that is believed to vary as afunction of the flux density of the gamma rays 40 emitted by marker 30a. Changes in this output signal are then converted into humanlyrecognizable detection information, e.g., sound, having acharacteristic, e.g., pitch or tempo in the case of sound, that varieswith changes in gamma ray flux density. By observing the location ofprobe 32 when the detection information from detector 34 indicates theprobe is closest to a given marker 30 a, the surgeon can mentally notewhere the marker is located. Repetition of this process will result inidentification of the location of all markers 30 a.

[0109] Referring to FIGS. 2b and 7, in the case of marker 30 b, whichgenerates a magnetic field 42, probe 32′ and detector 34′ are used todetect the marker. To locate a marker 30 b, the surgeon moves probe 32′in the general region of tissue volume 22, with the result that as theprobe approaches a given marker 30 b its Hall effect sensor (not shown)generates an output signal having a voltage that increases as the probeis moved toward the marker. Similarly the voltage of the output signaldecreases as probe 32′ is moved away from the marker 30 b. The outputsignal of probe 32′ is provided via line 120 to amplifier 122, whichamplifies the output signal from the probe. As discussed above, theamplified voltage signal from probe 32′ is displayed on signal meter 126and is also delivered to voltage controlled oscillator 128. The lattergenerates an oscillating signal, the frequency of which varies as afunction of the voltage of the amplified signal provided to voltagecontrolled oscillator 128. This signal is then amplified by amplifier130, and the amplified signal then drives speaker 116 such that thepitch of the sound provided by the speaker 116 varies as a function ofproximity of probe 32′ to marker 30 b. By observing signal meter 126and/or listening to speaker 116, the surgeon can assess when the probe32′ is positioned closest to a selected marker 30 b. Repetition of thisprocess will result in identification of the location of all of markers30 b.

[0110] Turning now to FIGS. 2c, 3 a, 3 b and 8, marker 30 c, whichgenerates an RF signal 44, is identified using probe 32″ and detector34″ in the following manner. RF exciter 60 is operated so as to producean RF exciter signal 46. More particularly, radio frequency generator 62(FIG. 3B) generates a radio frequency signal which is amplified by RFamplifier 64, following sensitivity adjustment using gain adjustment 66,with the amplified signal being provided to antenna 68 for transmissionto markers 30 c. RF exciter 60 is positioned sufficiently close tomarkers 30 c that RF exciter signal 46 is received by antenna 52 of themarkers and is of sufficient strength to drive radio frequency generator56 of the markers. Following detection and regulation by circuit 54(FIG. 3A) of the signal 46 received by antenna 52, radio frequencygenerator 56 generates an RF signal which is transmitted by antenna 52as RF signal 44. Each marker 30 c can transmit RF signal 44 at afrequency that is unique to the marker, while an RF exciter signal 46having a single frequency can be used for all of the markers 30 c, withthe frequency of signal 46 being different than the frequencies ofsignals 44.

[0111] Once exciter 60 has been activated so as to cause marker 30 c togenerate RF signal 44, detection of the marker commences. This isachieved by positioning probe 32″ (FIG. 8) on or adjacent skin 402adjacent tissue volume 22, and then monitoring proximity informationprovided by analog signal strength display 150 and/or speaker 116 ofdetector 34″. More specifically, following receipt of RF signal 44 byreceive antenna 140 of probe 32″, the signal is filtered by selectablenotch filter 142 of probe 32″. By correlating a given marker 30 c, e.g.,marker 30 c ₁, with a corresponding representation on the adjustmentknob (not shown) that controls selectable notch filter 142, e.g., thereference number “1,” the surgeon can identify the location of the givenmarker. The knob for adjusting selectable notch filter 142 is then movedto a different position when detecting a second marker 30 c, e.g.,marker 30 c ₂.

[0112] Signals from receive antenna 140 that are passed throughselectable notch filter 142 are then amplified by RF amplifier 144 withthe adjustment of the amplifier gain being provided as needed using gainadjustment 146. The amplified signal is then provided torectifier/integrator 148 where the signal is rectified and timefiltered. The strength of signal 144 detected by detector 34″ is thendisplayed via analog signal strength display 150 and is provided tovoltage controlled oscillator 152. The latter creates an oscillatingsignal, the frequency of which varies as a function of the voltage ofthe signal provided by rectifier/integrator 148. The output signal fromvoltage controlled oscillator 152 is then amplified by audio amplifier154 and delivered to drive speaker 116. The pitch of the sound providedby speaker 116 will vary as a function of the frequency of the signalprovided by voltage controlled oscillator 152, and as an ultimatefunction of the proximity of probe 32″ to a given marker 30 c. Byobserving the location of probe 32″ when the detection information fromdetector 34″ indicates the probe is closest to a given marker 30 c, thesurgeon can mentally note where the marker is located. By repeating thisprocess for each of the markers 30 c with appropriate adjustment ofselectable notch filter 142, all of the markers 30 c may be located.

[0113] Referring to FIGS. 2d, 3 a, 3 b and 8, marker 30 d may also bedetected using detector 34″ in substantially the same manner discussedabove with respect to marker 30 c. One significant difference, however,is the fact that RF exciter 60 (FIG. 3B) is not used insofar as marker30 d contains its own power source.

[0114] Turning next to FIGS. 2e, 2 f, and 4-6, for markers 30 e and 30f, which are designed to provide high image contrast when imaged withultrasound, probe 32 includes a conventional ultrasound transducer (notshown) that generates ultrasound in a conventional frequency range,e.g., 7.5 MHz, and receives back reflection of the ultrasound signal.Detector 34 is the image processor and display (neither shown) of aconventional ultrasound apparatus which is connected to the ultrasoundtransducer. Markers 30 e or 30 f are identified by scanning the generalregion of tissue volume 22 with probe 32, and monitoring the ultrasoundimage of the markers provided by detector 34. This ultrasound imagepermits the surgeon to identify the placement of all of the markers, andhence the boundaries of tissue volume 22.

[0115] In the case of marker 30 e, the latter is caused to vibrate at afrequency that is generally significantly less than that of theultrasound generated by the ultrasound transducer in probe 32. Thiscreates, through what is believed to be a Doppler shift phenomenon,enhanced image contrast in the ultrasound signal reflected off markers30 e. Vibration of a marker 30 e is effected by operating RF exciter 92so that radio frequency generator 94 generates a radio frequency signalwhich is amplified by amp 96 and then transmitted by antenna 100.Antenna 80 of marker 30 e receives this RF signal, which is detected andregulated by circuit 84 so as to generate an oscillating electricalsignal that is provided to piezoelectric device 86. This signal causesthe piezoelectric device 86 to mechanically oscillate, whichoscillations are transferred via support 88 to outer housing 90 ofmarker 30 e, thereby causing the housing (and hence the marker) tovibrate.

[0116] G. Tissue Removal

[0117] Following identification of tissue volume 22 using the proceduresoutlined above, surgical removal of the tissue volume commences.Referring to FIGS. 12 and 14, the first of the two procedures forremoving tissue volume 22 referenced above commences with the formationof an incision 404 (FIG. 12) in skin 402 above tissue volume 22. Thelength of incision 404 is typically about equal to, or slightly greaterthan, the distance between two markers 30 lying on a given axis, e.g.,the Y-axis as illustrated in FIG. 12. Next, portions of skin 402adjacent incision 404 are pulled apart by retractors or other knowndevices, so as to form open region 406 (FIG. 14) and expose tissueportion 24 beneath.

[0118] Referring now to FIGS. 9-11 and 15-17, as the next step, tissueanchor 300 is inserted in tissue mass 26 so as to assume the extendedposition illustrated in FIG. 11. This is achieved by inserting a fingerinto ring 302, then pulling rod 304 upwardly (as illustrated in FIG. 10)with respect to cannula 320 so that pin 308 moves in slot 328 toward theend thereof closest to proximal end 324 of the cannula. In thisretracted position, cannula 320 is grasped and is inserted through openregion 406 into tissue volume 22 so that its distal end 326 ispositioned substantially in the center of tissue mass 26. This placementmay be achieved under the guidance of an imaging system (not shown) thatis capable of imaging tissue anchor 300, e.g., ultrasound or X-rayimaging systems. Alternatively, using system 20, the location a marker302 lying beneath tissue volume 22, as illustrated in FIGS. 16 and 17,is identified using the procedure described above to identify the tissuevolume. By identifying the depth at which marker 302 is located andcomparing this to the length of cannula 320 inserted into tissue volume22, distal end 326 may be positioned centrally within tissue mass 26.

[0119] Next, ring 302, and hence rod 304 attached thereto, is forceddownwardly (as viewed in FIG. 15) relative to cannula 320 until pin 308contacts the end of slot 328 closest to distal end 326. As rod 304 moveswithin cannula 320 toward this extended position, anchor members 310 areforced out through apertures 330 and into tissue mass 26 (see FIG. 17).Then, ring 302, and hence rod 304, is rotated slightly so as to causepin 308 to move into pocket 329.

[0120] The next step in the removal of tissue volume 22 is assembly andplacement of a cutter 200 in open region 406. Referring to FIGS. 15 and18-20, the cutter 200 includes cutter portions 202 and 204 that can bepositioned adjacent open region 406, as illustrated in FIG. 15. Next,the cutter portion 202 is positioned in open region 406, and a curvedplate 206 of the cutter portion 202 is inserted under portions of skin402 adjacent the open region, as illustrated in FIG. 18. Next, thecutter portion 204 is similarly positioned in open region 406. Then,cutter portions 202 and 204 are moved toward one another so that cannula320 of tissue anchor 300 is received in an elongate groove 232 in acentral handle section 222 and in an elongate groove 255 in a centralhandle section 252. Cutter portions 202 and 204 are moved even closer toone another so that central handle sections 222 and 252 engage oneanother. When positioned in this manner, ends of curved portion 206 ofcutter portion 202 engage ends of curved portion 236 of cutter portion204 so as to form a substantially continuous curved cutting edge. Alsowhen positioned in this manner, a longitudinal axis of cutter 200extends substantially parallel to the elongate axis of cannula 320, bothof which are substantially co-axial with the Z-axis extending throughtissue volume 22. (See FIGS. 16 and 19).

[0121] Next, the position of cutter 200 relative to markers 30 isdetermined by comparing the location of markers, which is typicallydetermined by using probe 32 and detector 34 in the manner describedabove, to the position of the cutter. Then, the location of cutter 200is adjusted so that the longitudinal axis of cutter 200 is substantiallyco-axial with the Z-axis of the tissue volume 22, as illustrated in FIG.19. In some cases the surgeon will recall the location of markers 30from the prior marker identification step, and so it will be unnecessaryto again locate the markers. However, when tissue portion 24 isamorphous and pliable, as is the case when breast tissue is involved, itis recommended that this alignment of cutter 200 with tissue portions 30using probe 32 and detector 34 be performed before any cutting of tissuevolume 22 commences.

[0122] In connection with the initial insertion of cutter 200 in openportion 406, an appropriately sized cutter 200 is selected such that theradius of curved plates 206 and 236, as measured radially outwardly fromthe longitudinal axis, is substantially the same as the radius of tissuevolume 22 as measured radially outward from the Z-axis. While thisrelationship between the radii of curved plates 206 and 236 of cutter200 and the radius of tissue volume 22, as measured with respect toZ-axis, is preferred, in some cases it may be satisfactory to use acutter having a radius that is greater than or less than the radius ofthe tissue volume 22. Also, the height of curved portions 206 and 236 isanother factor considered in selecting an appropriate cutter 200.

[0123] Referring to FIGS. 16-20, as the next step in the removal oftissue volume 22, ring 302 of tissue anchor 300 is typically pulledupwardly in the direction of arrow F (see FIGS. 17 and 19) sufficientlyto tension tissue volume 22 and adjacent portions of tissue portion 24.By this tensioning of tissue volume 22 and tissue portion 24 thetendency of the tissue portion to compress under the force of a cuttingdevice is reduced. Also, this tensioning of tissue volume 22 serves tostabilize the tissue volume during the surgical removal process.

[0124] In some cases, sufficient tissue stabilization can be achievedmerely by holding tissue anchor 300 in a substantially fixed positionrelative to tissue volume 22. In other words, no force in the directionof arrow F is applied to tissue anchor 300 except as may be necessary tohold the tissue anchor in a stable position.

[0125] Then, while stabilizing tissue volume 22 with tissue anchor 300,preferably, but not necessarily by maintaining an upward force on thetissue anchor, the surgeon grips cutter 200 and begins pressingdownwardly toward tissue volume 22, i.e., in the direction of arrow D(see FIG. 21). At the same time, the cutter is rotated about itslongitudinal axis in either or both a clockwise and counterclockwisedirection, e.g., in the direction indicated by curved arrow R (see FIG.19). The elongate grooves 232 and 255 (FIG. 15) are sized to permitcutter 200 to rotate relatively freely about cannula 320 positionedtherein.

[0126] As cutter 200 is rotated about its longitudinal axis and is urgeddownwardly towards tissue volume 22, it cuts tissue volume 22 along itsouter boundary. Progress in removing tissue volume 22 is generallyperiodically determined by comparing the position of curved plates 206and 236 of cutter 200 relative to markers 30 using probe 32 and detector34 to identify the locations of markers 30 and then comparing suchlocations with the location of the cutter. In particular, adetermination can be made as to when tissue volume 22 has been severedfrom tissue portion 24 to a depth defined by marker 302 (FIG. 21)defining the bottom or innermost portion of the tissue volume. Thus, byiteratively comparing the position of cutter 200 to the locations ofmarkers 30 using marker location information acquired from detector 34based on proximity information provided by the detector, a surgeon candetermine when the cutting operation is completed and cutter 200 can beremoved from tissue portion 24, as indicated in FIG. 20.

[0127] Depending upon the size of cutter 200 relative to the placementof markers 30, the latter may remain in place in tissue portion 24following removal of tissue volume 22, as indicated in FIG. 20. If suchas the case, markers 30 are then subsequently removed by first locatingthe markers using probe 32 and detector 34 and then removing the markerswith a suitable instrument, e.g., tweezers. In other cases, the markerswill be included in the tissue volume 22.

[0128] In some cases, it will be necessary to sever the bottom orinnermost portion of tissue volume 22 from tissue portion 24 so as topermit removal of the tissue volume. A scalpel or other conventionaltool may be used to perform this final severing of the tissue volume.The precise location where this final incision is made may be determinedby again locating the position of marker 302 using probe 32 and detector34. By leaning tissue anchor 300 and cutter 200 to one side, a surgeoncan typically follow the incision created by cutter 200 with a scalpelor other tool down to the region where marker 302 is located and tissuevolume 22 remains attached to tissue portion 24.

[0129] As noted above, in some circumstances a marker 302 is notrequired when the bottom or innermost portion of tissue volume 22 ispositioned immediately above a different type of tissue, e.g., apectoral muscle 400. In such case, the surgeon can assess when cutter200 has been inserted sufficiently deep into tissue portion 24 by merelyobserving when bottom cutting edges of the cutter are about to engagethe different type of tissue.

[0130] Referring to FIG. 1A, by inserting markers 30 at staggeredlocations along the Z-axis, the relative depth of cutter 200 in tissueportion 24 can be determined by locating specific markers using probe 32and detector 34. The location of such markers 30 is then compared withthe location of cutter 200 to determine the depth of the cut. Forexample, if markers 30 c are installed at positions X₁ and X₂ in FIG.1a, and each marker has a unique frequency, these markers can beuniquely identified by detector 34″ (FIG. 8) in the manner describedabove.

[0131] Referring to FIG. 1B, by positioning more than four markers,e.g., eight markers as illustrated in FIG. 1B, the boundaries of tissuevolume 22 can often be more readily defined during the removal of thetissue volume. This is so because increasing the number of markers 30used increases the quantity of information received from detector 34regarding the boundaries of tissue volume 22.

[0132] While the use of cutter 200 in connection with the removal tissuevolume 22 often expedites removal of the tissue volume, many othercutters or instruments can be used to remove, treat, monitor, orotherwise perform some procedure on the tissue volume. In this regard, aconventional scalpel may often be satisfactorily employed in place ofcutter 200. Also, under certain circumstances it may be desirable toinitiate an incision with cutter 200, and then complete the incisionwith a scalpel. It will be appreciated that other types of cutters andsystems for manipulating the tissue can be used, such as using as vacuumto pull-up on the tissue, extending an “umbrella” at the end of astabilizer to pull-up on the tissue, vibrating the cutter to cut thetissue (either in lieu of or in addition to rotating the cutter), andusing rotational electrocautery.

[0133] The process of removing tissue volume 22 using a scalpel alsopreferably commences by inserting tissue anchor 300 in tissue volume 22in the manner described above. The location of markers 30 are alsodetermined prior to and during the removal of tissue volume 22 byscalpel in the manner described above. Thus, during the removal oftissue volume 22, the boundaries thereof may be repeatedly identified bylocating markers 30 using probe 32 and detector 34. As noted above, itis generally advantageous to use tissue anchor 300 when removing tissuevolume 22 with a scalpel because by stabilizing the tissue volume andsurrounding regions of tissue portion 24, it is easier to maintainalignment of the scalpel with the boundaries of the tissue volume.However, it is to be appreciated that the use of tissue anchor 300 is apreferred, but not essential, aspect of the present method of bracketingand removing tissue volume 22.

[0134] Referring now to FIG. 2g and FIG. 13, as noted above, probe 32and detector 34 are not used in connection with marker 30 g. Thedetection characteristic of markers 30 g is the release of a colored dye78 in surgical cavity adjacent the markers. In an alternativeembodiment, the markers can be capsules that each have a differentcolor, and the colored markers can be implanted in a manner to definethe desired margin for guidance during a percutaneous biopsy procedure,excisional procedures, and other procedures. Removal of a tissue volume22 bracketed by markers 30 g differs from the removal of tissue volumewhen bracketed by the other embodiments of marker 30 in that thelocation of marker 30 g is not determined by the surgeon prior toinitiation of the removal of tissue volume 22. Practically speaking,this is more a difference in the process for removing tissue volume 22than a difference in the composition and construction of marker 30 g.This is so because for implantation purposes, marker 30 g mustnecessarily be imageable by some form of imaging system, which imagingsystem could, in most cases, also be used by the surgeon to identify thelocation of marker 30 g prior to and in connection with the removal oftissue volume 22. For example, if marker 30 g is initially implanted byimaging the marker using an ultrasound system, then marker 30 g isactually a marker 30 f Thus, in connection with the followingdescription of the process of removing tissue volume 22 bracketed withmarkers 30 g, it is assumed the markers are not located by the surgeonprior to, or in connection with, the removal of tissue volume other thanby visual observation, as discussed below.

[0135] Removal of tissue volume 22 bracketed by markers 30 g alsopreferably commences by installing tissue anchor 300 as described above.Again, the use of tissue anchor 300 is preferred, but not mandatory.Next, the surgeon commences cutting the general region of tissue volume22, which can be defined by colored marks, Kopanz needles or other knowntechniques. Then, the removal of tissue volume 22 proceeds using eithercutter 200, or a scalpel or other cutting device. As this removal oftissue volume 22 is performed, tissue anchor 300, if used, ismanipulated to stabilize tissue volume 22 in the manner described above.As cutter 200, the scalpel or other cutting device (e.g., a vacuumassisted cutting device) encounters a marker 30 g, the capsule of themarker is severed releasing the colored dye 78. This advises the surgeonthat a boundary of tissue volume 22 has been encountered. It may beadvantageous to use a given color of dye in markers 30 g defining oneside of the boundary of tissue volume 22, while the markers 30 gdefining an opposite side include a different color of dye. By definingthe boundary of tissue volume 22 with a sufficient number, e.g., 10-25,of markers 30 g, the boundary of tissue volume 22 can typically beidentified by iteratively cutting and observing whether dye appears inthe surgical cavity.

[0136] As noted above, marker embodiments 30 a-30 f may all includecolored dye 78 within an outer capsule that is sufficiently tough towithstand insertion and yet is relatively easily cut by cutter 200, ascalpel or other cutting device. Such use of dye in markers 30 providesanother source of information for the surgeon regarding the boundary oftissue volume 22.

[0137] One advantage of certain embodiments of the tissue bracketingsystem 20 is that they permit the relatively precise identification ofthe boundaries of tissue volume 22 without the need for needles, wiresor other cumbersome apparatus projecting from tissue portion 24. Assuch, bracketing system 20 permits a surgeon to relatively quickly andeasily identify the tissue boundary of tissue volume 22 and remove thetissue volume. In addition, system 20 is ideally adapted for bracketinga tissue volume 22 in amorphous, pliable tissue, such as breast tissue.

[0138] Another advantage of certain embodiments of the cutter 200 isthat they permit a tissue volume 22 of relatively large diameter to beremoved through a relatively small incision 404 or percutaneously. Thisadvantage is useful in this era when tissue-conserving therapies arebeing emphasized.

[0139] By stabilizing tissue volume 22 using tissue anchor 300, theaccuracy with which a surgeon can remove tissue volume 22 is alsoenhanced compared to techniques that do not use a tissue stabilizer oranchor. Also, the accuracy of removing tissue may be further enhanced bydocking the tissue stabilizer or anchor to the first implanted tissuemarker by using a first marker in the tissue stabilizer and the positiondetection system. This advantage of the present embodiment arisesbecause tensioning of the tissue volume 22 by pulling upwardly on tissueanchor 300 serves to retain the tissue portion in a relatively stableposition. Indeed, even holding tissue anchor 300 in a substantiallyfixed position relative to the tissue volume 22 with which it is engagedtypically provides beneficial stabilization of the tissue volume.

[0140] While cutter 200 and tissue anchor 300 may be advantageouslyemployed in connection with the present method of bracketing andremoving tissue volume 22, it is to be appreciated that the cutter andtissue anchor have application in many other contexts. Morespecifically, in any application in which it is desired to remove avolume of tissue through as small an incision as possible, cutter 200has utility. Similarly, when it is desired to stabilize a piece oftissue in connection with surgical removal or other treatment of thepiece of tissue, whether or not within the bracketing context of thepresent invention, tissue anchor 300 also has important application.Likewise, the system of bracketing a tissue mass is also useful in otherapplications, such as radiation therapy, and in connection with otherbody parts.

[0141] Certain changes may be made in the above apparatus and processesshown in FIGS. 1-20 without departing from the scope of the presentinvention. As such, it is intended that all matter contained in thepreceding description or shown in the accompanying drawings shall beinterpreted in an illustrative and not in a limiting sense. For example,as explained below with reference to FIGS. 21-61, additional embodimentsin accordance with other aspects of the invention are also useful forlocating, monitoring, and or treating tissue masses and other body partswithin a human body.

[0142] II. Alternate Systems and Methods for Locating, Monitoring and/orTreating Target Locations Within a Human Body

[0143] A. Overview of System Components and Operation

[0144]FIG. 21 is an isometric view of a system 1000 for locating atarget location T within a human body H in accordance with oneembodiment of the invention. The target location T shown in FIG. 21 canbe a lesion, tumor, or other area of interest on or within a soft tissueregion (e.g., a breast “B”), an organ, the colon, a bone structure, oranother body part. The particular components of the system 1000 are bestunderstood in light of the relationship between the components and theoperation of the system. Therefore, the following description willinitially explain an overview of the components and the generaloperation of the system 1000.

[0145] In one embodiment, the system 1000 includes a wirelessimplantable marker 1100, an instrument 1120, a position detection system1200, and a user interface 1300. The wireless implantable marker 1100can be implanted at a precise location with respect to the targetlocation 1000 using stereotactic imaging systems and other proceduresknown in the art as explained above. In operation, the positiondetection system 1200 determines the location of the wirelessimplantable marker 1100 and the location of the instrument 1120 relativeto a reference location to determine the relative position between thetarget location T and the instrument 1120. The position detection system1200 is coupled to the user interface 1300 to convey the relativeposition between the target location 1000 and the instrument 1120 in amanner that allows a surgeon to intuitively understand the position andthe orientation of the instrument 1120 relative to the target location1000 without additional imaging equipment. As a result, the system 1000is particularly useful for applications in which the patient cannotimmediately proceed from an imaging procedure to another procedure, orwhen intraoperative imaging is not practical or economical.

[0146]FIG. 22 is an elevational view illustrating selected embodimentsof the wireless implantable marker 1100, the instrument 1120, and aportion of the position detection system 1200 in greater detail. Thewireless implantable marker 1100 can be one of the markers describedabove with reference to FIGS. 1-20. Alternatively, the wirelessimplantable marker 1100 can be a resonating marker or another type ofmarker as described below in more detail with reference to FIGS. 23A-33.In general, at least one wireless implantable marker 1100 is implantedat a location relative to the target location 1000. In the embodimentshown in FIG. 22, one wireless implantable marker 1100 is implantedwithin the target location T and another wireless implantable marker1100 is implanted adjacent to the target location T. In severalembodiments, the wireless implantable markers 1100 emit a responseenergy in reaction to an excitation energy emitted by the positiondetection system 1200. The position detection system 1200 can sense theintensity of the response energy and determine the location of theindividual implantable markers 1100 relative to a reference location.

[0147] This implementation could be used with a device that is at aknown location relative to the position detection system referencelocation. For example, an external beam radiation could be applied to atarget location defined by the first implantable marker or otherwisemonitored when the position of the beam applicator is known relative tothe reference location of the position detection system. A suitableexternal beam radiation device is the PRIMIS Linear Accelerator fromSiemens Medical of Concord, Calif.

[0148] The instrument 1120 can include a handle 1121, a function-site1124 coupled to the handle 1121, and at least one instrument marker1130. The function-site 1124 can be a tip of the instrument 1120 or aportion of the instrument 1120 that cuts, ablates, deposits, images orotherwise treats or monitors the target location T. Several embodimentsof various types of instruments with different function-sites aredescribed in more detail below with reference to FIGS. 40-52. Theinstrument markers 1130 can be the same type of wireless markers as theimplantable marker 1100, or alternatively the instrument markers 1130can be a different type of wireless marker. The instrument markers 1130can also be “wired” markers that are directly coupled to the positiondetection system 1200. The position detection system 1200 can also gaugethe instrument markers 1130 to determine the position of the instrumentrelative to a reference location.

[0149] In the embodiment shown FIG. 22, the instrument 1120 includesthree instrument markers 1130 including two instrument markers 1130 thatare attached to the instrument 1120 along an alignment axis A-A, and athird instrument marker 1130 that is offset from the alignment axis A-A.By knowing the distance between the function-site 1124 and the array ofinstrument markers 1130, the position detection system 1200 candetermine the position and the orientation of the function-site 1124based upon the positions of the three instrument markers 1130.

[0150] Referring to FIGS. 21 and 22 together, the position detectionsystem 1200 (FIG. 21) can include a processor 1202 (FIG. 21), adetection array 1204 having a plurality of sensors 1210, and atransmitter 1220 (FIG. 21). The transmitter 1220 can emit an excitationenergy that causes the implantable markers 1100 to emit a responseenergy. Each sensor 1210 can include three coils arranged orthogonallyaround a magnetic core to measure the response energy emitted from theimplantable markers 1100 and instrument 1130. The processor 1202calculates the distance between each sensor 1210 and each of the markers1100 and 1130 based upon the intensity of the response energy measuredby the sensors 1210. The processor 1202 also correlates the distancemeasurements between each of the markers 1100 and 1130 to determine theindividual locations of the markers 1100 and 1130 relative to areference location 1230 (e.g., a reference coordinate system). Basedupon this data, the processor 1202 and/or another processor of the userinterface 1300 can determine the relative position between thefunction-site 1124 of the instrument 1120 and the target location T.Suitable position detection systems 1200 and resonating signal elementsthat can be adapted for use with the implantable markers 1100 and/or theinstrument markers 1130 are available from Polhemus, Inc. of Burlington,Vt.

[0151] B. Embodiments of Wireless Markers

[0152]FIG. 23A is a cut-away isometric view of a resonating marker thatcan be used for the implantable markers 1100 and/or the instrumentmarkers 1130 in accordance with one embodiment of the invention. In thisembodiment, the resonating marker includes a casing 1140 composed of abiocompatible material, a signal element 1150 within the casing 1140,and a fastener 1160. The biocompatible material of the casing 1140 canbe a suitable polymeric material, metal, medical grade epoxy, glass, orother compound that can reside within a human body for a period of time.The signal element 1150 can be a resonating circuit that includes a core1152, a coil 1154 wrapped around the core 1152, and a capacitor 1156connected to the coil 1154. The core 1152 may be a magneticallypermeable material, such as a ferrite. The signal element 1150 emits aresponse signal in reaction to an excitation energy at the resonatefrequency of the circuit. As explained above, the excitation energy canbe generated by the transmitter 1220 (FIG. 21) of the position detectionsystem 1200. In other embodiments, the signal element 1150 can be amechanical resonator (e.g., piezoelectric actuator), an RF emitter, afluorescent material, a bipolar semiconductor, or another suitabledevice or material that emits a response signal in reaction to anexcitation energy. The fastener 1160 can have several differentembodiments. In this particular embodiment, the fastener 1160 is ashape-memory material that is straight in a stored position and coils toform a loop in a deployed position. The shape-memory material can be aspring, or it can be a substance that is straight at room temperatureand coils at body temperature.

[0153]FIG. 23B is an isometric cut-away view of another resonatingmarker in accordance with an embodiment of the invention. In thisembodiment, the resonating marker includes a biocompatible casing 1140and a signal element 1150 a. The marker can also include a fastener (notshown in FIG. 23B). The signal element 1150 a has three resonatingmembers 1151 a-c arranged orthogonally with respect to each other. Theresonating members 1151 a-c can also be configured in a non-orthogonalarrangement or any other suitable arrangement. Additionally, the signalelement 1150 a can include two or more resonating members such that thisembodiment of the resonating marker is not limited to having threeresonating members 1151 a-c. Each resonating member 1151 a-c can have aferrite core 1152, a coil 1154 wrapped around the core 1152, and acapacitor 1156 coupled to each coil 1154. Each resonating member 1151a-c can be tuned to resonate at the same frequency or at differentfrequencies. When the resonating members 1154 a-c resonate at differentfrequencies, this embodiment of a resonating marker can thus providethree different signals from a single marker so that the positiondetection system can detect not only the point position of the marker(e.g. an X-Y-Z location), but also the pitch, roll and yaw of the markerrelative to a coordinate system.

[0154]FIGS. 23C and 23D illustrate a resonating marker in accordancewith still another embodiment of the invention. In this embodiment, theresonating marker has a single core 1152 and three coils 1154 a-c. Eachcoil 1154 a-c can be coupled to a capacitor (not shown), and each coil1154 a-c can generate a different signal. As such, this marker can belocated in a manner similar to the marker described above with referenceto FIG. 23B. The core 1152 can accordingly be a ferrite block, and thecoils 1154 a-c can be wrapped around the block orthogonally to eachother as shown in FIG. 23D.

[0155] The resonating markers shown in FIGS. 23A and 23B areparticularly useful because they can remain within a human body for along period of time. These resonating markers can also have frequenciesthat are useful in applications in which a plurality of wireless markers1100 are implanted. In such situations, it may be necessary todistinguish the implanted markers from one another. By using resonatingmarkers that resonate at different frequencies, the position detectionsystem 1200 can identify the “signature” of each marker by its uniquefrequency. A surgeon, therefore, can easily identify the relativelocation between a particular implanted marker 1100 and an instrument1120.

[0156] FIGS. 24-30 are side elevation views of several implantablemarkers 1101-1107 in accordance with embodiments of the invention. Eachimplantable marker 1101-1107 shown in FIGS. 24-30 has a biocompatiblecasing 1140. Additionally, the implantable markers 1101-1107 can alsoinclude a signal element 1150 or 1150 a for emitting a resonatingsignal, such as a magnetic resonator, a mechanical resonator (e.g., apiezoelectric actuator), an RF emitter, a magnet, a fluorescentmaterial, or other suitable elements that can emit a signal fordetection by the position detection system 1200 (FIG. 21).

[0157] The implantable markers 1101-1107 have different types offasteners 1160. The implantable marker 1101 shown in FIG. 24 includes afastener 1160 defined by legs that project away from the casing 1140 inthe deployed position. The legs can be molded projections of the casing1140, or the legs can be small springs that are biased to project awayfrom the casing 1140. The implantable marker 1102 shown in FIG. 25includes a fastener 1160 defined by shape-memory loops on both ends ofthe casing 1140. In FIG. 26, the implantable marker 1103 has a fastener1160 defined by a surface texture, such as scales, that project awayfrom the casing 1140. The surface texture of the implantable marker 1103can be integrally formed with the casing 1140. Referring to FIG. 27, theimplantable marker 1104 can include a fastener 1160 defined by one ormore barbs or hooks. Referring to FIGS. 28 and 29, the implantablemarkers 1105 and 1106 have fasteners 1160 defined by a perforatedmaterial through which tissue can grow, such as a mesh. The implantablemarker 1105 shown in FIG. 28 has a perforated tip, and the implantablemarker 1106 shown in FIG. 29 has a perforated tail. Referring to FIG.30, the implantable marker 1107 includes a fastener 1160 defined by aspring or a serpentine element extending from the rear of the casing1140. It will be appreciated that the fasteners 1160 can have differentconfigurations than the particular types of fasteners 1160 shown inFIGS. 24-30.

[0158] FIGS. 31-33 are side elevation views of several embodiments ofimplantable markers 1108-1110 in accordance with additional embodimentsof the invention. The implantable markers 1108-1110 can include thebiocompatible casing 1140 for implantation into a human body. Theimplantable markers 1108-1110 also include at least one identifier 1170that is on and/or in the casing 1140. The identifier 1170 can be aradiopaque material that reflects radiation energy, an echogenicmaterial that reflects ultrasound energy, and/or a groove or channel inthe casing 1140 that can be observed by an imaging system.Alternatively, the identifiers 1170 can be a color or other marking thatis visually distinguishable for viewing with a human eye. Theidentifiers 1170 provide another feature for distinguishing one markerfrom another that can be used in addition to, or in lieu of, usingsignal elements 1150 that emit different frequencies. The implantablemarkers 1108-1110 can also include fasteners 1160 as described abovewith reference to FIGS. 24-30, and/or signal elements 1150 or 1150 a asdescribed above with reference to FIGS. 23A and 23B.

[0159]FIGS. 34 and 35 are isometric views of arrangements for implantingthe wireless implantable markers 1100 relative to the target location Tin accordance with embodiments of the invention. FIG. 34 illustrates anembodiment in which only a first wireless implantable marker 1100 a isimplanted in the target location T, and FIG. 35 shows an embodiment inwhich only the first wireless implantable marker 1100 a is implantedadjacent to or otherwise outside of the target location T. In eitherembodiment, the location of the implantable marker 1100 a relative tothe target location T is determined when the marker 1100 a is implantedor at another imaging procedure so that the marker 1100 a provides areference point for locating the target location T in subsequentprocedures. The user interface 1300 can electronically generate avirtual margin 1301 relative to the target location based uponparameters defined by the physician and the location of the implantablemarker 1100 a. In other embodiments, it is not necessary to generate thevirtual margin 1301 relative to the target location T. The physician candetermine the shape of the virtual margin 1301 so that it defines aboundary for performing a particular procedure at the target location T.The virtual margin 1301 is typically configured so that it defines thedesired boundary for the particular procedure at the target location Twithout unduly affecting adjacent areas. In the case of a lesion in asoft tissue region, for example, the physician can define a virtualmargin 1301 that encompasses the lesion and an appropriately sizedsafety zone around the lesion that mitigates collateral damage to tissueproximate to the lesion. The virtual margin 1301 can be spherical asshown in FIGS. 34 and 35, or it can have any desired shape includingrectilinear shapes, oval shapes, or compound shapes.

[0160] FIGS. 36-39 are isometric views of additional arrangements forimplanting the wireless implantable markers 1100 relative to the targetlocation T in accordance with other embodiments of the invention. FIG.36 illustrates an embodiment in which six individual implantable markers1100 a-1100 f are implanted in pairs along three orthogonal axes todefine an excision boundary or another type of margin around the targetlocation T. FIG. 37 shows an embodiment in which two individualimplantable markers 1100 a and 1100 b define a cylindrical margin aroundthe target location T. FIG. 38 illustrates an embodiment in whichindividual implantable markers 1100 a and 1100 b define an ovoid marginaround the target location T, and FIG. 39 illustrates an embodiment inwhich four implantable markers 1100 a-1100 d define a rectilinear marginaround the target location T. The individual implantable markers 1100a-1100 f can define an actual margin by bracketing the target locationT, or the positions of one or more of the individual markers 1100 a-1110f can be used to generate a virtual margin 1301 for use with the userinterface. Additionally, it will be appreciated that other arrangementsfor implanting the implantable markers 1100 and other types of marginscan be used depending upon the particular procedure, the type of bodypart, and the shape of the target location T.

[0161] C. Embodiments of Instruments

[0162] FIGS. 40-42 are cut-away side elevation views of instruments 1120in accordance with embodiments of the invention. The instruments 1120include the handle 1121, the function-site 1124 coupled to the handle1121, and at least one instrument marker 1130. The position detectionsystem 1200 (FIG. 1) can determine the position of the instrumentmarkers 1130 relative to a reference location. Referring to FIG. 40,this embodiment of the instrument 1120 includes a single instrumentmarker 1130 a at a predetermined location relative to the function-site1124. The embodiment of the instrument 1120 shown in FIG. 40 provides atleast a single position point for tracking by the position detectionsystem 1200. When the instrument marker 1130 is a single-axis marker,such as the marker shown in FIG. 23A, the instrument 1120 can bedisplayed as a single point by the user interface 1300 (FIG. 1). Theorientation of this particular embodiment of the instrument 1120 cannotbe displayed by the user interface 1300 because the single-axis markerdoes not provide sufficient data to determine the angle of the alignmentaxis A-A relative to a plane through the target location T (FIG. 1) orthe rotational position of the instrument 1120 around the alignment axisA-A. It may be possible, though, to have a single instrument marker 1130define the location and orientation of the instrument 1120 if theposition detection system 1200 and the instrument marker 1130 aresensitive enough to pinpoint the location and orientation of the singleinstrument marker 1130. For example, the multiple-axis markers shown inFIGS. 23B-D are expected to provide sufficient data to define thelocation and orientation of the instrument 1120 using a single marker.

[0163]FIG. 41 illustrates another embodiment of the instrument 1120having a first instrument marker 1130 a and a second instrument marker1130 b. The first instrument marker 1130 a is positioned at a firstpredetermined location relative to the function-site 1124, and thesecond instrument marker 1130 b is positioned at a second predeterminedlocation relative to the function-site 1124. The first and secondinstrument markers 1130 a and 1130 b can be positioned along thealignment axis A-A as shown in FIG. 41, or at least one of the markers1130 a or 1130 b can be offset from the alignment axis A-A. Theembodiment of the instrument 1120 shown in FIG. 41 accordingly providestwo position points that the position detection system 1200 can track.As a result, the position detection system 1200 can determine the angleof the alignment axis A-A relative to a reference plane so that the userinterface 1300 can display the instrument 1120 as (a) a vector ofvarying length when the alignment axis A-A is not normal to thereference plane, or (b) as a point when the alignment axis A-A is atleast approximately normal to the reference plane. When the instrumentmarkers 1130 a and 1130 b are multiple-axis markers, the rotationalorientation of the instrument 1120 relative to the alignment axis A-Acan be determined such that both the position of the function-site 1124and the orientation of the instrument 1120 can be displayed by the userinterface 1300.

[0164]FIG. 42 illustrates yet another embodiment of the instrument 1120having a first instrument marker 1130 a, a second instrument marker 1130b, and a third instrument marker 1130 c. The first and second instrumentmarkers 1130 a and 1130 b can be positioned along the alignment axisA-A, but the third instrument marker 1130 c is offset from the alignmentaxis A-A. This embodiment of the instrument 1120 provides three positionpoints for tracking by the position detection system 1200. As a result,the position detection system 1200 can determine (a) the angle of thealignment axis A-A relative to a reference plane, and (b) the rotationalorientation of the instrument 1120 around the alignment axis A-A. Theembodiment of the instrument 1120 shown in FIG. 42 accordingly permitsthe user interface 1300 to show the angle of the function-site 1124relative to a reference plane, and the orientation of a leading edge ofthe function-site 1124 relative to the motion of the instrument 1120.

[0165]FIG. 43 is a side elevational view of an embodiment of theinstrument 1120 including a wireless control 1132 for controlling anaspect of (a) the instrument 1120, (b) the position detection system1200, and/or (c) the user interface 1300 in accordance with anotherembodiment of the invention. The instrument 1120 shown in FIG. 43 hasthree instrument markers 1130 a-c, but will be appreciated that theinstrument 1120 can have any of one or more instrument markers 1130. Thewireless control 1132 includes an actuator 1133 and a transmitter 1134coupled to the actuator 1133. The transmitter 1134 transmits orotherwise emits a signal indicating a control parameter. The transmitter1134, for example, can be another marker that the position detectionsystem 1200 can track. In one particular embodiment, the transmitter1134 is a resonating magnetic marker having a signal element 1150 as setforth above with respect to FIG. 23. One advantage of using a resonatingmarker for the transmitter 1134 is that the system 1000 (FIG. 21) can becontrolled by a wireless instrument 1120 using the position detectionsystem 1200 without additional types of receivers (e.g., RF systems)that add to the complexity and cost of the system 100. Alternatively,the transmitter 1134 can be an RF device, a mechanical resonator, apermanent magnet, or another type of device that emits a frequency oranother form of energy. When the transmitter 1134 is a marker, theposition detection system 1200 detects the position of the transmitter1134 and generates a control signal according to the position of thetransmitter 1134.

[0166]FIG. 44 is a schematic view of one embodiment of the wirelesscontrol 1132. In this embodiment, the transmitter 1134 of the wirelesscontrol 1132 is a resonating marker having a resonating signal element1150 b similar to one of the signal elements 1150 or 1150 a shown abovein FIG. 23A or 23B. The signal element 1150 b includes a ferrite core1152, a coil 1154 wrapped around the core 1152, a capacitor 1156 coupledto the coil 1154, and a cut-off switch 1157 between the coil 1154 andthe capacitor 1156. The actuator 1133 can be a push-button coupled tothe cut-off switch 1157 that breaks the circuit to deactivate the signalelement 1150 b. In operation, the physician can press the actuator 1133to close the cut-off switch 1157 so that the signal element 1150 b emitsa resonating signal. The position detection system 1200 detects thesignal from the signal element 1150 b and generates a control signalthat changes a parameter of the system 1000. The position detectionsystem 1200, for example, can send a message to the user interface 1300to change a display of the user interface 1300 to show the relativeposition between the instrument 1120 and one of several implantedmarkers 1100. This is particularly useful when a plurality of markers1100 are implanted, such as the implanted markers 1100 a-f in FIG. 36,and the physician needs to know the position relative to a particularmarker. In one embodiment, the control 1132 can be used to cycle throughthe various markers 1100 a-f by depressing the actuator 1133 to movefrom one marker to the next. The wireless control 1132 can also haveseveral other applications that allow the position detection system 1200to control other aspects of the system 1000 based upon input at theinstrument 1120.

[0167]FIG. 45 is a schematic view of another embodiment of the wirelesscontrol 1132. In this embodiment, the actuator 1133 is a slidermechanism that moves along the handle 1121, and the transmitter 1134 isanother marker that can be detected by the position detection system1200. The actuator 1133, for example, can be a linear slider or arotational slider that has “click-stops” to indicate various controlpositions. In operation, the relative distance between the transmitter1134 and a fixed marker attached to the instrument (e.g., the secondinstrument marker 1130 b) is determined by the position detection system1200. A parameter of the instrument 1120, the position detection system1200, and/or the user interface 1300 can be controlled according to therelative distance between the transmitter 1134 and the fixed marker. Forexample, if the distance between the transmitter 1134 and the secondinstrument marker 1130 b is D₁, the user interface 1300 may display thedistance between the function-site 1124 of the instrument 1120 and afirst implanted marker. Similarly, if the distance between thetransmitter 1134 and the second instrument marker 1130 b is D₂, the userinterface 1300 may display the relative distance between thefunction-site 1124 and a second implanted marker.

[0168] FIGS. 46-52 illustrate several instruments 1120 a-g in accordancewith various embodiments of the invention. The instruments 1120 a-g caneach include a handle 1121, a function-site 1124 coupled to the handle1121, and at least one instrument marker 1130 similar to the instruments1120 described above with reference to FIGS. 40-42. The instruments 1120a-g can also include a wireless control similar to the wireless controls1132 described above with reference to FIGS. 43-45. The differencesbetween the instruments 1120 a-g is generally the type of function-site1124.

[0169]FIG. 46 illustrates a smart Bovie 1124 a that has a function-site1124 a defined by an RF cutting blade. Suitable RF cutting deviceswithout the instrument markers 1130 are available from Valley Lab ofBoulder, Colo., under the part number E2516 Reusable ElectrosurgicalPencil. FIG. 47 illustrates a scissors 1120 b that has a function-site1124 b defined by the cutting blades. FIG. 48 illustrates a harmonicscalpel 1120 c having a function-site 1124 c defined by a harmoniccutting tip. Suitable harmonic scalpels without the instrument markers1130 are available from Ethicon Endo Surgery of Cincinnati, Ohio, underthe part name ULTRACISION HARMONIC SCALPEL®. FIG. 49 illustrates alaproscope 1120 d having a function-site 1124 d defined by a distal endof the laproscope. Suitable laproscopes without the instrument markers1130 are available from US Surgical of Norwalk, Conn., under the partname SURGIVIEW® Multi-Use Disposable Laproscope. FIG. 50 illustrates anRF ablation device 1120 e having a function-site 1124 e with RF elements1137 through which RF energy is delivered to the target site T. The RFelements 1137 can be retractable into a cannula in a manner similar tothe tissue anchors 310 described above with reference to FIGS. 10 and11. Suitable RF ablation devices 1120 e without the instrument markers1130 are available from Radio Therapeutics Sunnyvale, Calif., under thepart name LeVeen Needle Electrodes. FIG. 51 illustrates a robotic probe1120 f having a function-site 1124 f defined by a distal tip of theprobe 1120 f The probe 1120 f can be used to mark reference fiducialsjust prior to a surgical procedure to map out a desired cutting path.FIG. 52 illustrates a scalpel 1120 g having a function-site 1124 gdefined by a cutting blade. Suitable scalpels without instrument markers1130 are available from Bard-Parker of Franklin Lake, N.J., such assingle-use Scalpel No. 11. It will be appreciated that FIGS. 46-52illustrate only a few of the types of instruments for use with thesystem 1000 (FIG. 21), and that other types of instruments can be usedwith the system 1000 by adding instrument markers 1130 that the positiondetection system 1200 can track.

[0170] D. Embodiments of User Interfaces

[0171] FIGS. 53-61 illustrate several embodiments of user interfaces1300 and methods for using the systems 20 and 1000 in accordance withthe invention. The user interfaces 1300 can be used with any of theimplantable markers 30 and 1100, and any of the instruments 200, 300 and1120 described above with reference to FIGS. 1-52. The user interface1300 is generally a computer display for graphically illustrating orotherwise presenting the position data generated by the positiondetection system 1200 to a user. The user interface 1300 canalternatively be an audio signal, a visual pattern based on light and/orcolor, a tactile or mechanical signal (e.g., vibrational), or otherindicators that can inform a physician of the relative position betweenthe instrument and the target location.

[0172]FIG. 53 is a schematic diagram illustrating an embodiment of thesystem 1000 for displaying the relative position between an instrument1120 and the target location T. In this embodiment, the system 1000includes an implantable marker 1100 implanted in the body part B, aninstrument 1120 for performing a procedure on the target location T, theposition detection system 1200, and the user interface 1300. Theimplantable marker 1100 and the instrument 1120 can be any one of theembodiments of these devices described above. The instrument 1120, morespecifically, has an instrument coordinate system 1129 defined by theorthogonal axes X_(i)-Y_(i)-Z_(i). The Z_(i)-axis is aligned with thealignment axis A-A, and the X_(i)-axis and Y_(i)-axis define anoperating plane normal to the Z_(i)-axis. The instrument coordinatesystem 1129 moves with the instrument during the procedure. The positiondetection system 1200 generally includes the same components describedabove with reference to FIGS. 21 and 22. As such, the position detectionsystem 1200 can include an array 1204 having sensors 1210 and atransmitter 1220 for emitting an excitation energy that drives theimplanted marker 1100 and the instrument markers 1130. The positiondetection system 1200 can also include a reference coordinate system1212 defined by three orthogonal axes X_(r)-Y_(r)-Z_(r). In operation,the position detection system 1200 determines the position of theimplanted marker 1100 and the positions of the instrument markers 1130relative to the reference coordinate system 1212 to determine therelative position between the function-site 1124 of the instrument 1120and the target location T. The position detection system 1200 can alsoinclude a processor.

[0173] The user interface 1300 provides a display or another type ofindicator of the relative position between the function-site 1124 andthe target location T based on data from the position detection system1200. In this embodiment, the user interface 1300 includes a processor1302, a memory 1304 coupled to the processor 1302, an input device 1306for controlling parameters of the system 1000, and an output display1310. The processor 1302 and the memory 1304 can be a computer availablefrom many sources. The input device 1306 can be a keyboard, a computermouse, a touch screen, or any other suitable device for inputtingcommands to the processor 1302. The output display 1310 is preferably adisplay screen, but it can also be another type of output device thatgenerates an output that can be detected and understood by a user. Theuser interface 1300 also includes a display coordinate system 1308defined by three orthogonal axes X_(d)-Y_(d)-Z_(d). The displaycoordinate system 1308 can initially correspond to the referencecoordinate system 1212 of the position detection system 1200. In manyapplications, however, it may not be desirable to view the display 1310based upon the reference coordinate system 1212. The processor 1302 canaccordingly calibrate the display coordinate system 1308 so that thedisplay 1310 shows a desired two-dimensional plane or a desiredthree-dimensional space.

[0174] In operation, the user interface 1300 processes data from theposition detection system 1200 in real-time to show the relative motionbetween the function-site 1124 and the target location T. For example,the processor 1302 receives signals from the position detection system1200 and produces output signals that can be represented by the outputdisplay 1310. As explained in more detail below, the user can set theparameters for generating the virtual margin 1301 and controlling otheraspects of the user interface 1300 using the input device 1306.

[0175]FIG. 53 also illustrates an orientation between the instrument1120 and the target location T that generally corresponds to acalibrating stage of a procedure for treating, probing, or monitoringthe target location T. The surgeon typically holds the instrument 1120so that the alignment axis A-A of the instrument 1120 defines a desiredZ_(i) elevation axis along which the surgeon moves the instrument 1120up and down relative to the target location T. The X_(i)-Y_(i) planenormal to the Z_(i)-axis defines the desired operating plane in whichthe surgeon moves the instrument 1120 along a margin M around the targetlocation T during a procedure. When the physician holds the instrument1120 relative to the target location T in a desired orientation forperforming the procedure, the instrument coordinate system 1129(X_(i)-Y_(i)-Z_(i)) may not be aligned with the reference coordinatesystem 1212 (X_(r)-Y_(r)-Z_(r)) and the display coordinate system 1308(X_(d)-Y_(d)-Z_(d)). The user interface 1300 accordingly calibrates thedisplay coordinate system 1308 to coincide with the instrumentcoordinate system 1129 so that the user interface 1300 indicatesmovement of instrument 1120 (a) along the alignment axis A-A as anelevation relative to the target location T, and (b) through theoperating plane X_(i)-Y_(i) as a location in an X-Y grid of the display1310.

[0176]FIG. 54A illustrates one embodiment of the user interface 1300showing the relative position between the instrument 1120 and the targetlocation T before calibrating the position detection system 1200 toalign the display coordinate system 1308 (FIG. 53) with the instrumentcoordinate system 1129 (FIG. 53). In this embodiment, the display 1310has a two-dimensional grid 1320 that shows the X_(d)-Y_(d) plane of thedisplay coordinate system 1308. The display 1310 can also include anumerical elevation indicator 1332 and/or a graphical elevationindicator 1334. The elevation indicators 1132 and 1134 show the positionalong the Z_(d)-axis of the display coordinate system 1308. Theinstrument 1120 is displayed as a line on the grid 1320 because the userinterface 1300 has not yet been calibrated to align the displaycoordinate system 1308 with the instrument coordinate system 1129. Thefunction-site 1124 of the instrument 1120 appears as a point at one endof instrument 1120, and the elevation of the function-site 1124 relativeto the target location T is displayed by one or both of the elevationindicators 1332 and 1334. At this stage before calibrating the userinterface 1300, it may be difficult for a physician to determine therelative position between the function-site 1124 and the target locationT because moving the instrument 1120 along the alignment axis A-Asimultaneously changes the position of the function-site 1124 on thegrid 1320 and on the elevation indicators 1332 and 1334. Therefore, toprovide a more intuitive display of the motion of the instrument 1120,the position detection system 1200 aligns the display coordinate system1308 with the instrument coordinate system 1129.

[0177] Referring to FIG. 54B, an example of an algorithm for performingthe calibration transformation is described as follows. The definitionsinclude Azimuth=ψ; Elevation=θ; Point before transformation=(a,b,c). Themathematical equation to convert this point into the X′,Y′,Z′ coordinatesystem; (a′,b′,c′). In the user interface, the marker would be at(0,0,0) after the implementation of the algorithms. The X, Y, Z axiswould still be oriented with the original coordinate system of thesystem reference. First rotate about the z-axis by the azimuth angle orψ. The point in this intermediary coordinate system is now defined as:

p=a*cos(ψ)+b*sin(ψ)

q=b*cos(ψ)−a*sin(ψ)

r=c

[0178] Next, rotate about the y-axis so that the z-axis is in line withthe probe. Effectively rotation will be about the y-axis by theelevation angle −90° or (θ−90°). The point in the X′,Y′,Z′ coordinatesystem would now be defined as:

a′=p*sin(θ)−r*cos(θ)

b′=q

c′=p*cos(θ)+r*sin(θ)

[0179] Substituting the values of p, q, and r into these equations thefollowing equation is obtained in terms of the original coordinates andthe azimuth and elevation angles:

a′=[a*cos(ψ)+b*sin(ψ)]*sin(θ)−c*cos(θ)

b′=b*cos(ψ)−a*sin(ψ)

c′=[a*cos(ψ)+b*sin(ψ)]*cos(θ)+c*sin(θ)

[0180] The point (a′,b′,c′) represents the original point (a,b,c)transformed into the new coordinate system. The user interface displayprobe tip projection math length projection on X-Y display plane isdefined by the equation:

Display Length=length probe tip*cosine(Elevation angle)

[0181] Based on these algorithms, a person skilled in the art canprogram the user interface 1300 to perform the calibration without undueexperimentation.

[0182]FIG. 55 illustrates an embodiment of the user interface 1300 ofFIG. 54 after the position detection system 1200 calibrates the userinterface 1300 to align the display coordinate system 1308 with theinstrument coordinate system 1129. In this embodiment, the instrument1120 and the function-site 1124 are both displayed as a point locationon the grid 1320. The elevation of the function-site 1124 relative tothe target location T still appears as a numeric or graphical readout onthe elevation indicators 1332 and 1334. After calibrating the coordinatesystems, the user interface 1300 accordingly shows (a) movement of theinstrument 1120 solely along the alignment axis A-A by changing only thereadout on the elevation indicators 1332 and 1334 without changing thelocation of the instrument 1120 on the grid 1320, and (b) movement ofthe instrument 1120 solely through the operating plane X_(i)-Y_(i) bychanging only the location of the instrument 1120 on the grid 1320without changing the readout on the elevation indicators 1332 and 1334.The position detection system 1200 and/or the user interface 1300 canalternatively continuously calibrate the system 1000 so that the displaycoordinate system 1308 continuously coincides with the instrumentcoordinate system 1129. In such an embodiment, the grid 1320 iscontinuously normal to the alignment axis A-A of the instrument 1120such that the display 1310 continuously displays the instrument 1120 asa point location (as shown in FIG. 55) irrespective of the orientationof the instrument 1120.

[0183]FIGS. 54A and 55 also illustrate one embodiment for defining avirtual margin 1301 relative to the target location T for use on thedisplay 1310 of the user interface 1300. As described above withreference to FIGS. 34-39, the virtual margin 1301 can be generated basedupon the position of an implantable marker 1100 or a plurality ofimplantable markers 1100. The virtual margin 1301 is generally definedby a physician based upon information from an imaging procedure, such aswhen the markers 1100 are implanted. The virtual margin 1301 can beconfigured to include a lesion, tumor, or other mass that defines thearea of interest at the target location T. The virtual margin 1301should be configured to avoid removing or otherwise performing aprocedure on material outside of the virtual margin 1301. As such, afterdetermining the relative position between the implantable marker 1100and the target location T using an imaging process (e.g., radiation,MRI, ultrasound, etc.), the physician determines the desired virtualmargin 1301 to input into the user interface 1300.

[0184] The physician can input the desired virtual margin 1301 into theuser interface 1300 using the input device 1306 of the user interface1300 or an instrument 1120 (e.g., the probe 1120 f shown in FIG. 51). Inone embodiment using a keyboard, the physician can enter a desiredradius relative to the target location T to define a spherical orcylindrical virtual margin 1301 that is displayed as a circle on thegrid 1320 of the display 1310. As explained above, the virtual margin1301 can also be configured to be rectilinear, a compound shape, or anyother suitable two-dimensional or three-dimensional shape that isdefined by the physician. The user interface 1300 accordingly displaysthe selected a virtual margin 1301 to define a boundary relative to thetarget location T. For example, the virtual margin 1310 is oftenconfigured to completely surround or encompass a tissue mass or otherbody part within the target location T. Referring still to FIGS. 54 and55, this embodiment of the invention illustrates a single implantablemarker 1100 disposed in the target location T and a spherical orcylindrical virtual margin 1301 around the implantable marker 1100.

[0185]FIG. 56 illustrates another embodiment for defining a virtualmargin 1301 relative to a target location T. In this embodiment, theuser interface 1300 can display an outline of the target location T(shown in broken lines), but it will be appreciated that the targetlocation T may not be displayed on the grid 1320. This embodiment of theinvention illustrates a single implantable marker 1100 disposed outsideof the target location T by an offset distance having coordinatedifferentials of “X” along an X-axis of the grid 1320, “Y” along theY-axis of the grid 1320, and “Z” (not shown) along an axis normal to aplane defined by the grid 1320. The offset distance can be determinedduring a previous imaging procedure or when the implantable marker 1100is implanted using known radiation, MRI, ultrasound and other imagingtechniques. Based upon the position of the implantable marker 1100 andthe offset distance between the implantable marker 1100 and the targetlocation T, the user interface 1300 can generate the virtual margin 1301around the actual location of the target location T. One advantage ofimplanting the marker 1100 outside of the target location T is that theimplantable marker 1100 does not pierce the tissue mass or other bodypart of the target location T. This feature can be particularly usefulin applications for removing cancerous tissue masses or other types oftissue/bone masses that are desirably left intact until they are removedfrom the patient.

[0186]FIG. 57 illustrates another embodiment for defining a virtualmargin 1301 relative to the target location T. In this embodiment, twoimplantable markers 1100 a and 1100 b have been implanted at twoseparate offset distances relative to the target location T. Thephysician can input two separate virtual margins 1301 a and 1301 brelative to the individual implantable markers 1100 a and 1100 b,respectively. In this particular embodiment, the virtual margin 1301 ais relative to the first implantable marker 1100 a and defines acylindrical boundary. Similarly, the virtual margin 1301 b is relativeto the second implantable marker 1100 b, but it defines a sphericalboundary. The virtual margins 1301 a and 1301 b together define acompound virtual margin relative to the target location T. It will beappreciated that several other virtual margins can be developed usingdifferent combinations of one or more implantable markers, and differentcombinations of markers that are implanted in and/or offset from thetarget location T. In any of the embodiments of the virtual margins 1301described above, the physician can manipulate an instrument 1120relative to the target location T using the user interface 1300 todisplay the relative position between the function-site 1124 of theinstrument 1120 relative to the virtual margin 1301.

[0187] FIGS. 58A-58C illustrate a procedure for operating the system1000 in accordance with one embodiment of the invention. In thisexample, a single implantable marker 1100 has been implanted within thetarget location T and the user interface 1300 has generated acylindrical or spherical virtual margin 1301 around the target locationT. Referring to FIG. 58A, the instrument 1120 is shown after the displaycoordinate system has been calibrated to be aligned with the instrumentcoordinate system in the manner explained above with reference to FIGS.53-55. The user interface 1300 initially displays the instrument 1120 asa point at a location A. Based upon this display, the physicianunderstands that the alignment axis A-A of the instrument 1120 is normalto the grid 1320 of the display 1310, and that the function-site 1124 ofthe instrument 1120 is at an elevation of 5 cm above a predeterminedreference plane relative to the target location T and/or the implantedmarker 1100 (see the elevation indicator 1332). The physician then movesthe instrument 1120 transverse relative to the alignment axis A-A to alocation B on the virtual margin 1301. In this particular embodiment,the physician held the instrument 1120 at a constant elevation of 5 cmabove the reference plane shown by the elevation indicator 1132.

[0188]FIG. 58B illustrates a subsequent stage of operating the system1000. After moving the instrument 1120 from location A to location B(FIG. 58A), the physician inserts the function-site 1124 of instrument1120 into the body part to move the function-site 1124 from the locationB to a location C. Referring to both FIGS. 58A and 58B, the elevationindicator 1132 shows that the elevation of the function-site 1124relative to the reference plane has moved from 5 cm above the referenceplane to 2 cm below the reference plane. In an application in which thephysician wants to excise a cylindrical tissue mass having a base 2 cmbelow the reference plane, the instrument 1120 at location C isaccordingly ready to be moved along the virtual margin 1301 to excise amass of tissue. Referring to FIG. 58C, the user interface 1300 displaysthe motion of the instrument as the physician or robot moves it alongthe virtual margin 1301. The virtual margin 1301 accordingly provides aguide to the physician that allows the physician to excise a precisevolume of tissue without cutting into the target mass or damaging tissueoutside of the target location T.

[0189]FIG. 59 illustrates another embodiment of the user interface 1300in accordance with the invention. In this embodiment, the display 1310includes a first grid 1320 illustrating a top view relative to areference plane and a second grid 1420 illustrating a front view normalto the reference plane. For purposes of convention, the reference planecan be parallel to the table on which the patient is positioned during aprocedure, but it can also be at an angle to the table. The display 1310can also include an elevation indicator 1132 showing the elevation ofthe function-site 1124 relative to the target location T and a distanceindicator 1432 showing the point-to-point distance between thefunction-site 1124 and the target location T. The embodiment of thedisplay 1310 shown in FIG. 59 provides the physician two separate viewsthat the physician can use to more accurately position the function-site1124 relative to the target location T. The operation and the advantagesof the display 1310 illustrated in FIG. 59 are expected to be similar tothose described above with reference to FIGS. 55-57.

[0190]FIGS. 60 and 61 illustrate additional embodiments of the userinterface 1300 in accordance with the invention. Referring to FIG. 60,the display 1310 provides a three-dimensional solid or opaquerepresentation of the virtual margin 1301. FIG. 61 illustrates anembodiment in which the display 1310 provides a holographicrepresentation of the virtual margin 1301 such that the target locationT can be represented within the holographic representation. Suitablesoftware for generating the three-dimensional representations of thevirtual margin 1301 illustrated in FIGS. 60 and 61 is available fromMedical Media System of West Lebanon, N.H. The three-dimensionalrepresentations of the virtual margin 1301 also provide a physician withan intuitive understanding of the relative position between thefunction-site 1124 of the instrument 1120 and the virtual margin 1301relative to the target location T. It is expected, therefore, that thethree-dimensional virtual margins 1301 will also allow physicians toaccurately perform procedures or monitor internal target locationswithin a human body without additional imaging equipment or procedures.

[0191] From the foregoing, it will be appreciated that specificembodiments of the invention have been described herein for purposes ofillustration, but that various modifications may be made withoutdeviating from the spirit and scope of the invention. Accordingly, theinvention is not limited except as by the appended claims.

What is claimed is:
 1. A system for locating a target location within ahuman body, comprising: a first wireless implantable marker configuredto be implanted within the human body at a location relative to thetarget location; an instrument having a function-site and a firstinstrument marker connected to the instrument at a first predeterminedsite relative to the function-site; a position detection system having asensor that detects a position of the first wireless implantable markerrelative to a reference location and a position of the first instrumentmarker relative to the reference location, wherein the positiondetecting system includes a computer that determines a relative positionbetween the first wireless implantable marker and the first instrumentmarker based on the positions of the first wireless marker and the firstinstrument marker relative to the reference location; and a userinterface operatively coupled to the position detection system, the userinterface having an indicator that denotes the position of thefunction-site of the instrument relative to the target location based onthe relative position between the first wireless implantable marker andthe first instrument marker.
 2. The system of claim 1 wherein the userinterface comprises a graphical display having a boundary relative tothe first implantable marker, and wherein the boundary defines a marginrelative to the target location.
 3. The system of claim 1 wherein theuser interface comprises a graphical display having a two-dimensionalgrid defining a plane and a boundary in the grid relative to the firstimplantable marker, and wherein the grid and the boundary define amargin relative to the target location in the plane.
 4. The system ofclaim 1 wherein the user interface comprises a graphical display havinga two-dimensional grid defining a plane, an elevation indicatorproviding an elevation of the function-site relative to the plane, and aboundary in the grid relative to the first implantable marker, andwherein the grid and the boundary define a margin relative to the targetlocation in the plane.
 5. The system of claim 1 wherein the elevationindicator comprises a numeric readout and/or a graphical representation.6. The system of claim 1 wherein the marker comprises a radioactiveisotope, and the position detection system comprises a device thatdetects a radiation level.
 7. The system of claim 1 wherein the userinterface comprises a graphical display having a three-dimensionalrepresentation that defines a margin relative to the target location. 8.The system of claim 1 wherein the user interface comprises a graphicaldisplay having a three-dimensional representation that defines an arearelative to the function site of the instrument.
 9. The system of claim1 wherein the user interface comprises a graphical display having afirst three-dimensional boundary relative to the first implantablemarker and a second three-dimensional boundary relative to the secondimplantable marker, and wherein the first and second three-dimensionalboundaries define a three-dimensional margin relative to the targetlocation.
 10. The system of claim 1 wherein the user interface comprisesa graphical display having an opaque three-dimensional representationthat defines a margin relative to the target location.
 11. The system ofclaim 1 wherein the user interface comprises a graphical display havingan opaque three-dimensional representation that defines a target an arearelative to the function site of the instrument.
 12. The system of claim1 wherein the user interface comprises a graphical display having afirst three-dimensional boundary relative to the first implantablemarker and a second three-dimensional boundary relative to the secondimplantable marker, and wherein the first and second three-dimensionalboundaries define a three-dimensional margin relative to the targetlocation.
 13. The system of claim 1 wherein: the system furthercomprises a second wireless implantable marker configured to beimplanted within the human body relative to the first implantable markerand the target location; the position detection system also detects aposition of the second wireless implantable marker relative to thereference location; and the user interface provides an indicator of theposition of the function-site of the instrument relative to the targetlocation based on the relative position between the first wirelessimplantable marker and the first instrument marker, and/or a relativeposition between the second wireless implantable marker and the firstinstrument marker.
 14. The system of claim 13 wherein the user interfacecomprises a graphical display having a first boundary relative to thefirst implantable marker and a second boundary relative to the secondimplantable marker, and wherein the first and second boundaries define amargin relative to the target location.
 15. The system of claim 13wherein the user interface comprises a graphical display having atwo-dimensional grid defining a plane, a first boundary in the gridrelative to the first implantable marker, and a second boundary in thegrid relative to the second implantable marker, and wherein the firstand second boundaries define a margin relative to the target location inthe plane.
 16. The system of claim 1 wherein: the instrument furthercomprises a second instrument marker connected to the instrument andaligned with the first instrument marker along an alignment axis; theposition detection system also detects a position of the secondinstrument marker relative to the reference location; and the userinterface provides an indicator of the position and orientation of thefunction-site based on the positions of the first and second instrumentmarkers relative to the reference location.
 17. The system of claim 1wherein the instrument further comprises a second instrument markerconnected to the instrument and aligned with the first instrument markerand the function-site along an alignment axis.
 18. The system of claim 1wherein: the instrument further comprises a second instrument markerconnected to the instrument and aligned with the first instrument markerand the function-site along an alignment axis; and the user interfacecomprises a graphical display having a two-dimensional grid defining aplane, an elevation indicator providing an elevation of thefunction-site relative to the plane, and an indicator showing theinstrument as a point on the grid when the alignment axis isapproximately normal to the plane or as a line when the alignment axisis not approximately normal to the plane.
 19. The system of claim 18wherein the grid and the boundary define a margin relative to the targetlocation in the plane.
 20. The system of claim 18 wherein the userinterface includes a line that varies in length relative to degree thatthe alignment axis is not normal to the plane.
 21. The system of claim 1wherein: the instrument further comprises a second instrument markerconnected to the instrument at a second site and a third instrumentmarker connected to the instrument at a third site, wherein at least oneof the second and third instrument markers are not aligned with thefirst instrument marker along an alignment axis; the position detectionsystem also detects a position of the second instrument marker and aposition of the third instrument marker relative to the referencelocation, and the user interface provides an indicator of the positionand orientation of the function-site based on the positions of thefirst, second, and third instrument markers relative to the referencelocation.
 22. The system of claim 1 wherein the instrument furthercomprises a wireless control for selecting a mode of operating the userinterface.
 23. The system of claim 22 wherein the wireless controlcomprises a cut-off switch that temporarily defeats a locationfunctionality of the first instrument marker.
 24. The system of claim 22wherein: the first instrument marker comprises a magnetic markerattached to the instrument; and the wireless control comprises amagnetic shield that blocks a magnetic field of the magnetic marker todefeat location functionality of the first instrument marker.
 25. Thesystem of claim 22 wherein: the first instrument marker comprises amechanical resonator marker attached to the instrument; and the wirelesscontrol comprises a dampening mechanism that cancels mechanicalvibrations of the mechanical resonator to defeat location functionalityof the first instrument marker.
 26. The system of claim 22 wherein: thewireless control comprises a slider marker that moves from a firstposition to a second position relative to the first instrument marker;and the position detection system detects a position of the slidermarker relative to the first instrument marker, and a functionality ofthe system is changed according to the relative position between theslider marker and the first instrument marker.
 27. The system of claim 1wherein the instrument further comprises a wireless control forselecting a mode of operating a component of the system.
 28. The systemof claim 27 wherein the wireless control comprises a cut-off switch thattemporarily defeats a location functionality of the first instrumentmarker.
 29. The system of claim 27 wherein: the first instrument markercomprises a magnetic marker attached to the instrument; and the wirelesscontrol comprises a magnetic shield that blocks a magnetic field of themagnetic marker to defeat location functionality of the first instrumentmarker.
 30. The system of claim 27 wherein: the first instrument markercomprises a mechanical resonator marker attached to the instrument; andthe wireless control comprises a dampening mechanism that cancelsmechanical vibrations of the mechanical resonator to defeat locationfunctionality of the first instrument marker.
 31. The system of claim 1wherein: the instrument further comprises a second instrument markeralong the alignment axis; the user interface comprises a graphicaldisplay having a two-dimensional grid defining a plane, wherein the userinterface continuously displays the two-dimensional plane orthogonalrelative to the alignment axis.
 32. The system of claim 1 wherein theinstrument comprises a tissue stabilizer probe.
 33. The system of claim1 wherein the instrument comprises a cutting tool.
 34. The system ofclaim 33 wherein the cutting tool comprises a scalpel.
 35. The system ofclaim 33 wherein the cutting tool comprises a minimally invasive cuttingdevice.
 36. The system of claim 33 wherein the cutting tool comprises abovie knife.
 37. The system of claim 33 wherein the cutting toolcomprises an ultrasonic cutting device.
 38. The system of claim 16wherein the cutting tool comprises scissors.
 39. The system of claim 1wherein the instrument comprises a radio frequency tissue ablationprobe.
 40. The system of claim 1 wherein the instrument comprisescryogenic tissue ablation probe.
 41. The system of claim 1 wherein theinstrument comprises interstitial laser probe.
 42. The system of claim 1wherein the instrument comprises a laproscopic probe.
 43. The system ofclaim 1 wherein the instrument comprises a robotic surgery probe.
 44. Asystem for locating a target location, comprising: a first wirelessimplantable marker configured to be implanted into a body at a locationrelative to the target location, wherein the first wireless marker emitsa wireless signal; and a position detection system having an energysource that emits an excitation energy and a sensor that detects aposition of the first wireless implantable marker relative to areference location.
 45. The system of claim 44, further comprising auser interface coupled to the position detection system, wherein theuser interface includes an indicator of a boundary relative to the firstwireless marker defining a desired margin around the target location.46. The system of claim 44, further comprising a user interface coupledto the position detection system, wherein the user interface includes anindicator of a first target position relative to the first wirelessmarker defining the target location.
 47. A wireless marker forimplantation, comprising: a biocompatible casing configured to beimplanted into a human body relative to a target location within thehuman body; a signal element in the casing, the signal element beingconfigured to emit a response energy in reaction to an excitationenergy; and a fastener configured to hold the wireless marker at areference location in a human body relative to the target locationwithin the human body
 48. The wireless marker of claim 47 wherein thesignal element comprises an electronic circuit resonator.
 49. Thewireless marker of claim 47 wherein the signal element comprises amagnetic resonator.
 50. The wireless marker of claim 47 wherein thesignal element comprises a radio frequency marker.
 51. The wirelessmarker of claim 47 wherein the signal element comprises a mechanicalresonator.
 52. The wireless marker of claim 47 wherein the signalelement comprises a magnet.
 53. The wireless marker of claim 47 whereinthe signal element comprises a fluorescent material.
 54. The wirelessmarker of claim 47 wherein the fastener comprises a protrusion integralwith the casing.
 55. The wireless marker of claim 47 wherein thefastener comprises an adhesive material.
 56. The wireless marker ofclaim 47 wherein the fastener comprises a protein that binds and/oradheres to tissue.
 57. The wireless marker of claim 47 wherein thefastener comprises a polymer that binds and/or adheres to tissue. 58.The wireless marker of claim 47 wherein the fastener comprises a biasingmember that is biased to expand from a stored position to a deployedposition.
 59. The wireless marker of claim 47 wherein the fastenercomprises a biasing member that is biased to contract from a storedposition to a deployed position.
 60. The wireless marker of claim 47wherein the fastener is a spring material element that forms a loop tograsp tissue in a deployed position.
 61. A wireless marker forimplantation, comprising: a biocompatible casing configured to beimplanted into a human body relative to a target location within thehuman body; and an identifier on and/or in the casing that can beobserved by an imaging system to distinguish the casing from othercasings that have been implanted into the human body.
 62. The wirelessmarker of claim 61 wherein the identifier comprises metal bands aroundthe casing.
 63. The wireless marker of claim 61 wherein the identifiercomprises a shape of the casing.
 64. The wireless marker of claim 61,further comprising a fastener configured to hold the wireless marker ata reference location relative to the target location, and wherein theidentifier comprises a shape of the fastener.
 65. A wireless marker forimplantation, comprising: a biocompatible casing configured to beimplanted into a human body relative to a target location within thehuman body; and an identifier on and/or in the casing that can beobserved visually to distinguish the casing from other casings that havebeen implanted into the human body.
 66. The wireless marker of claim 65wherein the identifier comprises metal bands around the casing.
 67. Thewireless marker of claim 65 wherein the identifier comprises a shape ofthe casing.
 68. The wireless marker of claim 65, further comprising afastener configured to hold the wireless marker at a reference locationrelative to the target location, and wherein the identifier comprises ashape of the fastener.
 69. The wireless marker of claim 65 wherein theidentifier comprises unique colors of the wireless marker casing.
 70. Aninstrument for manipulation within a human, comprising: a handle; afunction-site coupled to the handle, the function-site being alignedwith an alignment axis; a first instrument marker along the alignmentaxis; and a second instrument marker along the alignment axis.
 71. Aninstrument for manipulation within a human, comprising: a handle; afunction-site coupled to the handle, the function-site being alignedwith an alignment axis; and a first wireless instrument marker along thealignment axis, wherein the first wireless instrument marker emits awireless signal that can be detected by a position detection system todetermine a position of the first wireless instrument marker relative toa reference location.
 72. An instrument for manipulation within a human,comprising: a handle; a function-site coupled to the handle, thefunction-site being aligned with an alignment axis; a first wirelessinstrument marker along the alignment axis, wherein the first wirelessinstrument marker emits a wireless signal that can be detected by aposition detection system to determine a position of the first wirelessinstrument marker relative to a reference location; and a user interfaceattached to the instrument and coupled to the detection system, whereinthe user interface includes an indicator of a relative position betweenthe function-site and a target location within the human.
 73. A systemfor locating a target location within a human body, comprising: aninstrument having a handle, a function-site coupled to the handle, andat least one instrument maker attached to the instrument at apredetermined location relative to the function-site; and a detectionsystem that detects a characteristic of the instrument marker anddetermines a configuration of the instrument and/or the function-site.74. The system of claim 73 wherein the instrument marker configurationcomprises a location of the instrument marker.
 75. The system of claim73 wherein the instrument marker configuration comprises a markerresonator frequency.
 76. A method of providing information for aprocedure in which a first wireless implantable marker is implanted in ahuman body relative to a target location and an instrument marker iscoupled to an instrument at a predetermined site relative to afunction-site on the instrument, the method comprising: emitting aresonating energy from the first wireless implanted marker; sensing alocation of the first wireless marker relative to a reference location;sensing a location of the instrument marker relative to the referencelocation; correlating a relative position between the first wirelessmarker and the instrument marker based on the sensed locations; anddetermining a relative position between the function-site and the firstwireless implanted marker by adding together the relative positionbetween the first wireless marker and the target location, a relativeposition between the instrument marker and the function-site, and therelative position between the first wireless marker and the instrumentmarker.
 77. The method of claim 76, further comprising: comparing theposition of the function-site to the target location; and providing anindication of the position of the function-site relative to the targetlocation.
 78. The method of claim 76 wherein, if the first wirelessmarker is implanted in the target location, then the method furthercomprises generating a virtual margin to extend at least partiallyaround the marker.
 79. The method of claim 76 wherein, if the firstwireless marker is implanted adjacent to the target location such thatthe marker in offset from the target location, and the method furthercomprises generating a virtual margin to extend at least partiallyaround the target location.
 80. A method of treating a target locationwithin a human body, comprising: exciting a wireless marker implanted inthe body by emitting an excitation energy in a manner that causes themarker to emit a response energy; sensing the response energy; anddetermining a position of the wireless marker relative to a referencelocation based on the sensed response energy.
 81. The method of claim80, further comprising directing an intra-operative radiation energyrelative to the determined position of the wireless marker.
 82. Themethod of claim 80, further comprising monitoring an intra-operativeradiation energy relative to the determined position of the wirelessmarker.
 83. The method of claim 80, further comprising directing anexternal beam radiation energy relative to the determined position ofthe wireless marker.
 84. The method of claim 80, further comprisingmonitoring an external beam radiation energy relative to the determinedposition of the wireless marker.
 85. The method of claim 80, furthercomprising directing a brachy radiation energy relative to thedetermined position of the wireless marker.
 86. The method of claim 80,further comprising monitoring brachy radiation energy relative to thedetermined position of the wireless marker.